Comparing of the Clinical Outcome of Periodontal Accelera... | NCT05441683

Label	Type	Description	Intervention Names
HEI group	Experimental	PAOO with horizontal extending incisions on both sides	Procedure: horizontal extending incision
VRI group	Active Comparator	PAOO with vertical releasing incisions on both sides	Procedure: vertical releasing incision

Name	Type	Description	Arm Group Labels	Other Names
horizontal extending incision	Procedure	a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Then horizontally extending incisions will be added to each side of the initial incision, extending one to two teeth beyond the defected area, before a full-thickness flap is lifted.

Measure	Description	Time Frame
Surgery Time	Timing will start when the first incision is about to be made, and end when the last suture is complete. The time in between will be recorded as surgery time.	1 day

Measure	Description	Time Frame
Probing Depth (PD)	Distance from gingival margin to base of periodontal pocket. It will be measured at baseline and 3 months, 6 months, and 12months after surgery.	12 months
Clinical Attachment Level (CAL)

Measure	Description	Time Frame
Particulate Bone Grafting Material Weight	The net weight of the bone graft material before surgery is recorded as W1. After surgery, the remaining bone graft material was collected, dried, and weighed by the same electronic scale as W2. The amount of bone graft material used during surgery was calculated as ΔW=W1-W2.	1 day

Name	Affiliation	Role
Yanmin Wu	2nd Affiliated Hospital, School of Medicine, Zhejiang University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
2nd Affiliated Hospital, School of Medicine, Zhejiang University		Hangzhou	Zhejiang	310000	China

PubMed Identifier	Type	Citation	Retractions
41462182	Derived	Chen Y, Jiang K, Bian Z, Chen X, Lin Q, Yang Y, Zhang Z, Li B, Sun G, Tan J, Wu Y. Comparison of vertical releasing incisions and horizontal extending incisions for periodontal accelerated osteogenic orthodontics in the anterior region: a randomized controlled trial with clinical and radiographic outcomes. BMC Oral Health. 2025 Dec 29;25(1):1950. doi: 10.1186/s12903-025-07270-x.

ID	Title	Description
FG000	HEI Group	PAOO with horizontally extending incisions on both sides horizontally extending incisions (HEIs): a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Then horizontally extending incisions will be added to each side of the initial incision, extending one to two teeth beyond the defected area, before a full-thickness flap is lifted.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	May 11, 2022

ID	Title	Description
BG000	HEI Group	Periodontal Accelerated Osteogenic Orthodontics (PAOO) with horizontally extending incisions on both sides horizontally extending incision: a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Then horizontally extending incisions will be added to each side of the initial incision, extending one to two teeth beyond the defected area, before a full-thickness flap is lifted.
BG001	VRI Group	Periodontal Accelerated Osteogenic Orthodontics (PAOO) with vertical releasing incisions on both sides vertical releasing incision: a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Vertical releasing incisions will be made on each side of the initial incision before a full-thickness flap is lifted.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00010 BG00110 BG00220
teeth	BG00060 BG00157 BG002117

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Surgery Time

Timing will start when the first incision is about to be made, and end when the last suture is complete. The time in between will be recorded as surgery time.

Posted

Mean

Standard Deviation

minutes

1 day

ID	Title	Description
OG000	HEI Group	PAOO with horizontally extending incisions on both sides horizontally extending incisions (HEIs): a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Then horizontally extending incisions will be added to each side of the initial incision, extending one to two teeth beyond the defected area, before a full-thickness flap is lifted.
OG001	VRI Group	PAOO with vertical releasing incisions on both sides Vertical releasing incisions (VRIs):a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Vertical releasing incisions will be made on each side of the initial incision before a full-thickness flap is lifted. The incision formed an oblique trapezoidal flap with a wider base.

Units	Counts
Participants	OG00010 OG00110

Title

Denominators

Categories

Title	Measurements
	OG00057.66± 5.01 OG00168.50± 13.50

Secondary

Probing Depth (PD)

Distance from gingival margin to base of periodontal pocket. It will be measured at baseline and 3 months, 6 months, and 12months after surgery.

Posted

Mean

Standard Deviation

millimeter

12 months

teeth

ID	Title	Description
OG000	HEI Group	PAOO with horizontally extending incisions on both sides horizontally extending incisions (HEIs): a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Then horizontally extending incisions will be added to each side of the initial incision, extending one to two teeth beyond the defected area, before a full-thickness flap is lifted.
OG001	VRI Group	PAOO with vertical releasing incisions on both sides Vertical releasing incisions (VRIs):a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Vertical releasing incisions will be made on each side of the initial incision before a full-thickness flap is lifted. The incision formed an oblique trapezoidal flap with a wider base.

Units	Counts
Participants

Secondary

Clinical Attachment Level (CAL)

Distance from CEJ to base of periodontal pocket. It will be measured at baseline and 3 months, 6 months, and 12months after surgery.

Posted

Mean

Standard Deviation

millimeter

12 months

teeth

ID	Title	Description
OG000	HEI Group	PAOO with horizontally extending incisions on both sides horizontally extending incisions (HEIs): a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Then horizontally extending incisions will be added to each side of the initial incision, extending one to two teeth beyond the defected area, before a full-thickness flap is lifted.
OG001	VRI Group	PAOO with vertical releasing incisions on both sides Vertical releasing incisions (VRIs):a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Vertical releasing incisions will be made on each side of the initial incision before a full-thickness flap is lifted. The incision formed an oblique trapezoidal flap with a wider base.

Units	Counts
Participants

Secondary

Keratinized Gingival Width (KGW)

From mucogingival junction to free gingival margin It will be measured at baseline and 3 months, 6 months, and 12months after surgery.

Posted

Mean

Standard Deviation

millimeter

12 months

teeth

ID	Title	Description
OG000	HEI Group	PAOO with horizontally extending incisions on both sides horizontally extending incisions (HEIs): a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Then horizontally extending incisions will be added to each side of the initial incision, extending one to two teeth beyond the defected area, before a full-thickness flap is lifted.
OG001	VRI Group	PAOO with vertical releasing incisions on both sides Vertical releasing incisions (VRIs):a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Vertical releasing incisions will be made on each side of the initial incision before a full-thickness flap is lifted. The incision formed an oblique trapezoidal flap with a wider base.

Units	Counts
Participants

Secondary

Gingival Recession Depth (GRD)

Distance from CEJ to gingival margin. It will be measured at baseline and 3 months, 6 months, and 12months after surgery.

Posted

Mean

Standard Deviation

millimeter

12 months

teeth

ID	Title	Description
OG000	HEI Group	PAOO with horizontally extending incisions on both sides horizontally extending incisions (HEIs): a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Then horizontally extending incisions will be added to each side of the initial incision, extending one to two teeth beyond the defected area, before a full-thickness flap is lifted.
OG001	VRI Group	PAOO with vertical releasing incisions on both sides Vertical releasing incisions (VRIs):a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Vertical releasing incisions will be made on each side of the initial incision before a full-thickness flap is lifted. The incision formed an oblique trapezoidal flap with a wider base.

Units	Counts
Participants

Secondary

Root Length

the distance from the CEJ to the apex of the root. It will be measured at baseline, 6 months, and 12months after surgery.

Posted

Mean

Standard Deviation

millimeter

12 months

teeth

ID	Title	Description
OG000	HEI Group	PAOO with horizontally extending incisions on both sides horizontally extending incisions (HEIs): a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Then horizontally extending incisions will be added to each side of the initial incision, extending one to two teeth beyond the defected area, before a full-thickness flap is lifted.
OG001	VRI Group	PAOO with vertical releasing incisions on both sides Vertical releasing incisions (VRIs):a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Vertical releasing incisions will be made on each side of the initial incision before a full-thickness flap is lifted. The incision formed an oblique trapezoidal flap with a wider base.

Units	Counts
Participants

Secondary

Vertical Bone Height (VBL)

the distance from the cemento-enamel junction to the crest of the labial alveolar bone.

It will be measured at baseline, 6 months, and 12months after surgery.

Posted

Mean

Standard Deviation

millimeter

12 months

teeth

ID	Title	Description
OG000	HEI Group	PAOO with horizontally extending incisions on both sides horizontally extending incisions (HEIs): a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Then horizontally extending incisions will be added to each side of the initial incision, extending one to two teeth beyond the defected area, before a full-thickness flap is lifted.
OG001	VRI Group	PAOO with vertical releasing incisions on both sides Vertical releasing incisions (VRIs):a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Vertical releasing incisions will be made on each side of the initial incision before a full-thickness flap is lifted. The incision formed an oblique trapezoidal flap with a wider base.

Units	Counts
Participants

Secondary

Alveolar Bone Width Measured at 2 mm Below the CEJ (BW2)

Alveolar bone width measured at 2 mm below the CEJ on the labial side of the alveolar bone, representing the distance from the tooth root surface to the labial bone surface.It will be measured at baseline, 6 months, and 12months after surgery.

Posted

Mean

Standard Deviation

millimeter

12 months

teeth

ID	Title	Description
OG000	HEI Group	PAOO with horizontally extending incisions on both sides horizontally extending incisions (HEIs): a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Then horizontally extending incisions will be added to each side of the initial incision, extending one to two teeth beyond the defected area, before a full-thickness flap is lifted.
OG001	VRI Group	PAOO with vertical releasing incisions on both sides Vertical releasing incisions (VRIs):a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Vertical releasing incisions will be made on each side of the initial incision before a full-thickness flap is lifted. The incision formed an oblique trapezoidal flap with a wider base.

Secondary

Alveolar Bone Width Measured at 4 mm Below the CEJ (BW4)

Alveolar bone width measured at 4 mm below the CEJ on the labial side of the alveolar bone, representing the distance from the tooth root surface to the labial bone surface.It will be measured at baseline, 6 months, and 12months after surgery.

Posted

Mean

Standard Deviation

millimeter

12 months

teeth

ID	Title	Description
OG000	HEI Group	PAOO with horizontally extending incisions on both sides horizontally extending incisions (HEIs): a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Then horizontally extending incisions will be added to each side of the initial incision, extending one to two teeth beyond the defected area, before a full-thickness flap is lifted.
OG001	VRI Group	PAOO with vertical releasing incisions on both sides Vertical releasing incisions (VRIs):a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Vertical releasing incisions will be made on each side of the initial incision before a full-thickness flap is lifted. The incision formed an oblique trapezoidal flap with a wider base.

Secondary

Alveolar Bone Width Measured at 6 mm Below the CEJ (BW6)

Alveolar bone width measured at 6 mm below the CEJ on the labial side of the alveolar bone, representing the distance from the tooth root surface to the labial bone surface.It will be measured at baseline, 6 months, and 12months after surgery.

Posted

Mean

Standard Deviation

millimeter

12 months

teeth

ID	Title	Description
OG000	HEI Group	PAOO with horizontally extending incisions on both sides horizontally extending incisions (HEIs): a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Then horizontally extending incisions will be added to each side of the initial incision, extending one to two teeth beyond the defected area, before a full-thickness flap is lifted.
OG001	VRI Group	PAOO with vertical releasing incisions on both sides Vertical releasing incisions (VRIs):a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Vertical releasing incisions will be made on each side of the initial incision before a full-thickness flap is lifted. The incision formed an oblique trapezoidal flap with a wider base.

Secondary

Number of Participants With Visible Scarring

Gingival scarring was evaluated at 12 months postoperatively through visual inspection. Participants were classified as scar-positive if any visible scar was present at the surgical site, including normotrophic scars (flat and white) and pathological scars (raised or irregular in shape).

Each participant was counted once regardless of scar characteristics.

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	HEI Group	Periodontal Accelerated Osteogenic Orthodontics (PAOO) with horizontally extending incisions on both sides horizontally extending incision: a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Then horizontally extending incisions will be added to each side of the initial incision, extending one to two teeth beyond the defected area, before a full-thickness flap is lifted.
OG001	VRI Group	Periodontal Accelerated Osteogenic Orthodontics (PAOO) with vertical releasing incisions on both sides vertical releasing incision: a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Vertical releasing incisions will be made on each side of the initial incision before a full-thickness flap is lifted.

Secondary

Pain Level

measured with visual analogue score (VAS): 0 (no pain/normal sensation) to 10 (intolerable pain/complete numbness)

Posted

Mean

Standard Deviation

score on a scale

2 weeks

ID	Title	Description
OG000	HEI Group	PAOO with horizontally extending incisions on both sides horizontally extending incisions (HEIs): a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Then horizontally extending incisions will be added to each side of the initial incision, extending one to two teeth beyond the defected area, before a full-thickness flap is lifted.
OG001	VRI Group	PAOO with vertical releasing incisions on both sides Vertical releasing incisions (VRIs):a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Vertical releasing incisions will be made on each side of the initial incision before a full-thickness flap is lifted. The incision formed an oblique trapezoidal flap with a wider base.

Units	Counts
Participants

Secondary

Membrane Exposure

membrane exposure was observed and assessed as a binary outcome (yes/no). Recorded "no" if there is no membrane exposure, and "yes" if there is any membrane exposure.

Posted

Count of Participants

Participants

2 weeks

ID	Title	Description
OG000	HEI Group	PAOO with horizontally extending incisions on both sides horizontally extending incisions (HEIs): a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Then horizontally extending incisions will be added to each side of the initial incision, extending one to two teeth beyond the defected area, before a full-thickness flap is lifted.
OG001	VRI Group	PAOO with vertical releasing incisions on both sides Vertical releasing incisions (VRIs):a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Vertical releasing incisions will be made on each side of the initial incision before a full-thickness flap is lifted. The incision formed an oblique trapezoidal flap with a wider base.

Units	Counts
Participants

Secondary

Facial Swelling

recorded "0" for no facial swelling; "1" for mild facial swelling; "2" for severe facial swelling. It will be measured at 1 and 2 weeks after surgery.

Posted

Count of Participants

Participants

2 weeks

ID	Title	Description
OG000	HEI Group	PAOO with horizontally extending incisions on both sides horizontally extending incisions (HEIs): a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Then horizontally extending incisions will be added to each side of the initial incision, extending one to two teeth beyond the defected area, before a full-thickness flap is lifted.
OG001	VRI Group	PAOO with vertical releasing incisions on both sides Vertical releasing incisions (VRIs):a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Vertical releasing incisions will be made on each side of the initial incision before a full-thickness flap is lifted. The incision formed an oblique trapezoidal flap with a wider base.

Units	Counts
Participants

Secondary

Mucosal Color

recorded "0" for no redness along the incision; "1" for slight redness; "2" for obvious redness. It will be measured at 1 and 2 weeks after surgery.

Posted

Count of Participants

Participants

2 weeks

ID	Title	Description
OG000	HEI Group	PAOO with horizontally extending incisions on both sides horizontally extending incisions (HEIs): a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Then horizontally extending incisions will be added to each side of the initial incision, extending one to two teeth beyond the defected area, before a full-thickness flap is lifted.
OG001	VRI Group	PAOO with vertical releasing incisions on both sides Vertical releasing incisions (VRIs):a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Vertical releasing incisions will be made on each side of the initial incision before a full-thickness flap is lifted. The incision formed an oblique trapezoidal flap with a wider base.

Units	Counts
Participants

Secondary

Mucosa Edema

recorded "0" for no edema around the surgery area; "1" for mild edema; "2" for severe edema.It will be measured at 1 and 2 weeks after surgery.

Posted

Count of Participants

Participants

2 weeks

ID	Title	Description
OG000	HEI Group	PAOO with horizontally extending incisions on both sides horizontally extending incisions (HEIs): a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Then horizontally extending incisions will be added to each side of the initial incision, extending one to two teeth beyond the defected area, before a full-thickness flap is lifted.
OG001	VRI Group	PAOO with vertical releasing incisions on both sides Vertical releasing incisions (VRIs):a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Vertical releasing incisions will be made on each side of the initial incision before a full-thickness flap is lifted. The incision formed an oblique trapezoidal flap with a wider base.

Units	Counts
Participants

Other Pre-specified

Particulate Bone Grafting Material Weight

The net weight of the bone graft material before surgery is recorded as W1. After surgery, the remaining bone graft material was collected, dried, and weighed by the same electronic scale as W2. The amount of bone graft material used during surgery was calculated as ΔW=W1-W2.

Posted

Mean

Standard Deviation

1 day

ID	Title	Description
OG000	HEI Group	PAOO with horizontally extending incisions on both sides horizontally extending incisions (HEIs): a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Then horizontally extending incisions will be added to each side of the initial incision, extending one to two teeth beyond the defected area, before a full-thickness flap is lifted.
OG001	VRI Group	PAOO with vertical releasing incisions on both sides Vertical releasing incisions (VRIs):a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Vertical releasing incisions will be made on each side of the initial incision before a full-thickness flap is lifted. The incision formed an oblique trapezoidal flap with a wider base.

ID	Term
D014076	Tooth Diseases
D009057	Stomatognathic Diseases

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	HEI Group	PAOO with horizontally extending incisions on both sides horizontally extending incisions (HEIs): a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Then horizontally extending incisions will be added to each side of the initial incision, extending one to two teeth beyond the defected area, before a full-thickness flap is lifted.	0	11	0	11	0	11
EG001	VRI Group	PAOO with vertical releasing incisions on both sides Vertical releasing incisions (VRIs):a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Vertical releasing incisions will be made on each side of the initial incision before a full-thickness flap is lifted. The incision formed an oblique trapezoidal flap with a wider base.	0	11	0	11	0	11