Guided Tissue Regeneration With a Periodontal Dressing | NCT05756946

Studies
Guided Tissue Regeneration With a Periodontal Dressing

NCT05756946

Sponsor

Arab American University (Palestine)

Status

Completed

Last Update Posted

Jul 20, 2023Actual

Enrollment

24Actual

Phase

Not Applicable

Conditions

Periodontal Diseases

Interventions

periodontal dressing (coe-pak)
Guided Tissue Regeneration

Countries

Palestinian Territories

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2023Actual

Primary Completion Date

Apr 10, 2023Actual

Completion Date

Apr 15, 2023Actual

First Submitted Date

Feb 15, 2023

First Submission Date that Met QC Criteria

Feb 23, 2023

First Posted Date

Mar 7, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 19, 2023

Last Update Posted Date

Jul 20, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mahmoud Abu-Ta'a, Associate Professor, Arab American University (Palestine)Principal Investigator

Lead Sponsor

Arab American University (Palestine)OTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This randomized, controlled split-mouth study will include 24-40 patients. After GTR, a test and a control side will be selected by means of a computer-generated randomization list. Test sides will receive a periodontal dressing (Coepak") for 14 days and the control sides will receive no periodontal dressing. After 14 days the periodontal dressing will be removed and the pain experience will be recorded. After 6-9 months, the clinical periodontal parameters will be recorded.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Test group	Experimental	Test group will receive GTR + periodontal dressing (Coe-pak)	Procedure: periodontal dressing (coe-pak) Procedure: Guided Tissue Regeneration
Control group	Active Comparator	Control group will receive GTR only	Procedure: Guided Tissue Regeneration

Interventions

Name	Type	Description	Arm Group Labels	Other Names
periodontal dressing (coe-pak)	Procedure	Guided tissue regeneration and periodontal dressing	Test group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain experience	pain experience will be measured 14 days after GTR procedure; when the dressing is removed. Participants have to fill a VAS score out about pain intensity on a scale from 0 to 10 (0 = no pain, 5 = moderate pain and 10 = worst imaginable pain) and the amount of pain medication taken will be recorded	14 days

Secondary Outcomes

Measure	Description	Time Frame
Probing pocket depth	changes in periodontal probing pocket depth in mm	6 months
Attachment level	changes in clinical attachment level in mm

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age between 18 and 75 years.
- A minimum of 18 teeth, wisdom teeth excluded.
- Previously untreated moderate chronic periodontitis (Armitage 1999) with radiographic evidence of generalized alveolar bone loss >30%.
- Presence of at least one pocket with probing pocket depth (PPD) ≥6 mm per quadrant, which was BOP.
- Presence of at least three teeth per quadrant.

Exclusion Criteria:

Periodontal treatment in the last 3 years.
- Antibiotic intake 6 months before • the screening visit.
- Pregnancy. Systemic diseases with an impact on periodontal healing (e.g. Dia- betes).

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mahmoud Abu-Ta'a	Department of Dental sciences, Faculty of Graduate Studies, Arab American University (AAUP)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mahmoud Abu-Ta'a		Ramallah			Palestinian Territories

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010510	Periodontal Diseases

Ancestor Terms

ID	Term
D009059	Mouth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010511	Periodontal Dressings
C033390	Coe-Pak
D048091	Guided Tissue Regeneration

Ancestor Terms

ID	Term
D010517	Periodontics
D003813	Dentistry
D019651	Plastic Surgery Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided