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Microsurgical coronally advanced tunnel procedures using subepithelial connective tissue grafts (sCTG) are predictable for healing of multiple adjacent type 1 and 2 gingival recessions (RT1 and RT2). In order to reduce patient morbidity and enhance periodontal wound healing with sCTG can be used. The aim of this study is to compare the results of the modified tunneling technique with subepithelial connective tissue graft in gingival recessions placed with the inner side towards the flap cover graft and the outer side towards the flap cover graft.
Condition or disease:Multiple Gingival Recession
Intervention/treatment:
Device: Modified coronally advanced tunnel with connective tissue graft placed with inner side towards the flap Device: Modified coronally advanced tunnel with subepithelial connective tissue graft with the outer side towards the flap Phase :Not Applicable
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The tunnel technique for root coverage with CTG with outer side of the graft | Active Comparator | Procedure: A modified microsurgical tunnel technique. Initial sulcular incisions with a microsurgical blade are followed by a full-thickness buccal flap preparations till muco-gingival junction using the tunneling knives. Subsequently, the split-thickness preparation is extended into the mucosal tissue to gain sufficient flap mobility. The papillary regions are detached in their buccal aspects with the periosteum. The graft is inserted the /inner outer side into the tunnel and stabilized with absorbable suspensory sutures. The buccal flap is advanced coronally and stabilized with non-absorbable suspensory sutures. 21 participants were enrolled into the study, as it was designed to be a split mouth study |
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| The tunnel technique for root coverage with CTG with inner side of the graft | Experimental | Procedure: A modified microsurgical tunnel technique. Initial sulcular incisions with a microsurgical blade are followed by a full-thickness buccal flap preparations till muco-gingival junction using the tunneling knives. Subsequently, the split-thickness preparation is extended into the mucosal tissue to gain sufficient flap mobility. The papillary regions are detached in their buccal aspects with the periosteum. The graft is inserted the /inner outer side into the tunnel and stabilized with absorbable suspensory sutures. The buccal flap is advanced coronally and stabilized with non-absorbable suspensory sutures. 21 participants were enrolled into the study, as it was designed to be a split mouth study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The tunnel technique for root coverage with CTG with inner side of the graft | Procedure | Tunnel technique for root coverage with a subepithelial connective tissue graft (CTG). A split-thickness mucogingival tunnel will be prepared without vertical releasing incisions. The CTG will be inserted into the tunnel and positioned so that the inner (deep) side of the graft faces the inner surface of the flap (standardized graft orientation). The graft will be stabilized with sutures, and the flap will be coronally advanced to completely cover the graft. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Gingival Recession (Mean Root Coverage, MRC) | Mean root coverage (MRC) was calculated as the percent change in gingival recession height from baseline to 6 months using the formula: (GR0 - GR6) / GR0 × 100%.
| Baseline and 6 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| GR Change (Gingival Recession Height Change) GT Change (Gingival Thickness) KTW Change (Keratinized Tissue Width) | The analyzed metrics were calculated as follows: GR change= GR0-GR6 (after 6 months); ) [millimetre] higher scores mean better outcome GT change = GT6-GT0 (after 6 months); [millimetre] higher scores mean better outcome KTW change = KTW6-KTW0 (after 6 months); [millimetre] higher scores mean better outcome
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| Measure | Description | Time Frame |
|---|---|---|
| Root Coverage Esthetic Score (RES) | RES:The following variables were assessed:
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bartłomiej Górski, PhD | Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw | Warsaw | MAzowsze | 00-246 | Poland |
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| ID | Title | Description |
|---|---|---|
| FG000 | The Tunnel Technique for Root Coverage With CTG With Inner Side of the Graft | A modified microsurgical tunnel technique. Initial sulcular incisions with a microsurgical blade are followed by a full-thickness buccal flap preparations till muco-gingival junction using the tunneling knives. Subsequently, the split-thickness preparation is extended into the mucosal tissue to gain sufficient flap mobility. The papillary regions are detached in their buccal aspects with the periosteum. The graft is inserted the /inner outer side into the tunnel and stabilized with absorbable suspensory sutures. The buccal flap is advanced coronally and stabilized with non-absorbable suspensory sutures. 21 participants were enrolled into the study, as it was designed to be a split mouth study |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
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| 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 | Oct 4, 2024 |
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| The tunnel technique for root coverage with CTG with outer side of the graft | Procedure | Tunnel technique for root coverage with a subepithelial connective tissue graft (CTG). A split-thickness mucogingival tunnel will be prepared without vertical releasing incisions. The CTG will be inserted into the tunnel and positioned so that the outer side of the graft faces the inner surface of the flap. The graft will be stabilized with sutures, and the flap will be coronally advanced to completely cover the graft. |
|
| 6 months after surgery |
| 6 months after surgery |
| FG001 | The Tunnel Technique for Root Coverage With CTG With Outer Side of the Graft | Procedure: A modified microsurgical tunnel technique. Initial sulcular incisions with a microsurgical blade are followed by a full-thickness buccal flap preparations till muco-gingival junction using the tunneling knives. Subsequently, the split-thickness preparation is extended into the mucosal tissue to gain sufficient flap mobility. The papillary regions are detached in their buccal aspects with the periosteum. The graft is inserted the /inner outer side into the tunnel and stabilized with absorbable suspensory sutures. The buccal flap is advanced coronally and stabilized with non-absorbable suspensory sutures. 21 participants were enrolled into the study, as it was designed to be a split mouth study |
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| COMPLETED |
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| NOT COMPLETED |
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A total of 21 participants were enrolled. Due to the split-mouth design, the same participants contributed sites to both groups; therefore, participant numbers are identical across arms.
| ID | Title | Description |
|---|---|---|
| BG000 | Modified Coronally Advanced Tunnel With Connective Tissue Graft With Inner Side of the Graft | This was a randomized split-mouth clinical trial. Each participant received both interventions: one side was treated with the tunnel technique with a connective tissue graft (inner side), and the contralateral side with the same technique using the outer side of the graft. Assignment was at the gingival recession defect level. |
| BG001 | Modified Coronally Advanced Tunnel With Connective Tissue Graft With Outer Side of the Graft | This was a split-mouth study. Each participant contributed sites to both interventions. Participants may appear in more than one arm because the unit of assignment was the gingival recession site. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Gingival recession defects |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | This was a split-mouth study design. Each participant could contribute gingival recession defects to both intervention groups. Therefore, the number of participants in each arm is the same, while the total number of unique participants is 21. The unit of analysis was the gingival recession defects. | Number | Participants | Participants |
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| Sex/Gender, Customized | This was a split-mouth study design. Each participant could contribute gingival recession defects to both intervention groups. Therefore, the number of participants in each arm is the same, while the total number of unique participants is 21. The unit of analysis was the gingival recession defects. | Number | Participants | Participants |
| |||||||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
| |||||||||||||||||||||||
| Gingival recession height at baseline | Baseline gingival recession height was measured at the individual site level (gingival recession defects) and summarized for each intervention group. | Mean | Standard Deviation | Milimeters | Gingival recession defects |
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| 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 | Percent Change in Gingival Recession (Mean Root Coverage, MRC) | Mean root coverage (MRC) was calculated as the percent change in gingival recession height from baseline to 6 months using the formula: (GR0 - GR6) / GR0 × 100%.
| Posted | Mean | Standard Error | Percent change (%) | Baseline and 6 months after surgery | Gingival Recessions | Gingival Recessions |
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| Secondary | GR Change (Gingival Recession Height Change) GT Change (Gingival Thickness) KTW Change (Keratinized Tissue Width) | The analyzed metrics were calculated as follows: GR change= GR0-GR6 (after 6 months); ) [millimetre] higher scores mean better outcome GT change = GT6-GT0 (after 6 months); [millimetre] higher scores mean better outcome KTW change = KTW6-KTW0 (after 6 months); [millimetre] higher scores mean better outcome
| Posted | Mean | Standard Error | millimetres (mm) | 6 months after surgery | gingival recessions | gingival recessions |
| |||||||||||||||||||||||||||||||
| Other Pre-specified | Root Coverage Esthetic Score (RES) | RES:The following variables were assessed:
| Posted | Mean | Standard Error | score on a scale | 6 months after surgery | gingival recessions | gingival recessions |
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From enrollment until end of follow-up (6 months).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Modified Coronally Advanced Tunnel With Connective Tissue Graft With Inner Side of the Graft | Procedure: A modified microsurgical tunnel technique by Zuhr et al. (2007). Initial sulcular incisions with a microsurgical blade are followed by a split-thickness buccal flap preparations using the tunneling knives. The preparation is extended into the mucosal tissue to gain sufficient flap mobility. The papillary regions are detached in their buccal aspects with the periosteum. The graft is inserted with outer side into the tunnel and stabilized with absorbable suspensory sutures. The buccal flap is advanced coronally and stabilized with non-absorbable suspensory sutures. The tunnel technique for root coverage with CTG with inner side of the graft | 0 | 21 | 0 | 21 | 0 | 21 |
| EG001 | MCAT With SCTG With Outer Side of the Graft | Procedure: A modified microsurgical tunnel technique by Zuhr et al. (2007). Initial sulcular incisions with a microsurgical blade are followed by a split-thickness buccal flap preparations using the tunneling knives. The preparation is extended into the mucosal tissue to gain sufficient flap mobility. The papillary regions are detached in their buccal aspects with the periosteum. The graft is inserted with outer side into the tunnel and stabilized with absorbable suspensory sutures. The buccal flap is advanced coronally and stabilized with non-absorbable suspensory sutures. The tunnel technique for root coverage with CTG with outer side of the graft | 0 | 21 | 0 | 21 | 0 | 21 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| dr Bartłomiej Górski | Department of Periodontology and Oral Mucosa Diseases of Medical University of Warsaw | (22)2701616 | sluzowki@wum.edu.pl |
| Jan 6, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D005889 | Gingival Recession |
| ID | Term |
|---|---|
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D055093 | Periodontal Atrophy |
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| Title | Measurements |
|---|---|
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| ≥ 65 years |
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| Gingival recession defects |
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| Gingival recession defects |
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| Gingival recession defects |
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The study was designed as a randomized split-mouth clinical trial. Each participant received the same intervention. One side was treated with the tunnel technique with subepithelial connective tissue graft with outer side of the graft , while the other side was treated with the same method with outer side of the graft This was a split-mouth study. Each participant contributed sites to both interventions. Participants may appear in more than one arm because the unit of assignment was the gingival recession site. |
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|
The study was designed as a randomized split-mouth clinical trial. Each participant received the same intervention. One side was treated with the tunnel technique with subepithelial connective tissue graft with inner side of the graft , while the other side was treated with the same method with outer side of the graft This was a split-mouth study. Each participant contributed sites to both interventions. Participants may appear in more than one arm because the unit of assignment was the gingival recession site. |
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