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Xenogenic Collagen Matrix and Subepithelial Connective Tissue Graft in the Treatment of Gingival Recession

Primary Purpose

Gingival Recession Localized Moderate

Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
(XCM)+(CAF)
(SCTG)+(CAF)
Sponsored by
Damascus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession Localized Moderate focused on measuring Xenogenic collagen matrix (XCM)., subepithelial connective tissue graft (SCGT)., coronally advanced flap (CAF)., Root coverage.

Eligibility Criteria

18 Years - 47 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Good general health.
  • No contraindications for periodontal surgery.
  • Presence of one localized gingival recession in each side of the maxilla and/or mandible, All recessions will be Class I defects (Miller 1985).
  • The cemento-enamel junction (CEJ) is visible in the defective teeth.
  • All patients demonstrating good plaque control.
  • No previous periodontal surgery in the targeted area.

Exclusion Criteria:

  • Smokers.
  • pregnant or nursing patients.
  • history of malignancy, radiotherapy, or chemotherapy.
  • Patients taking medications that affect mucosal healing.
  • Patients with allergy to collagen.
  • Previous participation in a clinical trial.
  • Type-1 diabetes patients.
  • Patient who have diseases that affect connective tissue metabolism.

Sites / Locations

  • Department of Periodontics, University of Damascus Dental School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

(XCM)+(CAF)

(SCTG)+(CAF)

Arm Description

Surgical protocol for test treatment with CAF + XCM: After local anesthetizing the recipient site,CAF elevation will be done using (De Sanctis & Zucchelli 2007) design.Horizontal incisions will be done at the recession site,another two slightly divergent vertical incisions will be done at the end of previous incisions extending to the mucogingival junction.The resulting flap will be split thickness in the surgical papillae area,then will be full thickness exposing 3-4 mm of the bone apically of the dehiscence and after that it will be split thickness in the apical direction,all the muscle insertions will be eliminated,the root surface will be prepared by curettes and chemically treated with 24% EDTA gel.De-epithelialization of the interdental papillae will be done.The XCM will be trimmed and fix onto the root surface 1-2mm coronally of the CEJ using absorbable sutures,and the flap will be coronally advanced to fully cover the XCM and then sutured to the de-epithelialized papillae.

The surgical protocol in the control group will be identical with test group protocol with these exceptions: The entire flap will be elevated as split thickness instead of split-full-split thickness flap. A SCTG harvested from the palate will be used to cover the exposed denuded root surface in lieu of placement of XCM in the test group. And absorbable sutures will be used to stabilize it 2 mm coronally from the CEJ. As in the test group the mucosal flap will coronally advanced to completely cover the SCTG then sutured to the de-epithelialized papillae.

Outcomes

Primary Outcome Measures

Recession depth (REC): (Change in the amount of root coverage)
from the free gingival margin to the cemento-enamel junction at the mid-buccal aspect. Using University of North Carolina periodontal probe UNC15 (Medesey®-Italy).

Secondary Outcome Measures

change in visible plaque index:
Score 0 - No plaque Score 1 - Separate flecks of plaque at the cervical margin of the tooth Score 2 - A thin continuous band of plaque at the cervical margin of the tooth Score 3 - A band of plaque wider then 1mm covering less than 1/3rd of the crown of the tooth Score 4 - Plaque covering at least 1/3rd but less than 2/3rd of the crown of the tooth Score 5 - Plaque covering 2/3rd or more of the crown of the tooth
Recession width (RW)
at the cemento-enamel junction using periodontal probe of University of North Carolina UNC15 (Medesey®-Italy).
Width of keratinized tissue (KT)
from the free gingival margin to the mucogingival junction using periodontal probe of University of North Carolina UNC15 (Medesey®-Italy).
Thickness of gingival tissue (GT)
with an injection needle and a silicon marker, at the mid-buccal aspect below the gingival margin.
Probing depth (PD)
the distance between the gingival margin and the bottom of the pocket measured at the mid-buccal aspect of the tooth using periodontal probe of University of North Carolina UNC15 (Medesey®-Italy).
Clinical attachment level (CAL)
distance between the CEJ and the bottom of the pocket measured at the mid-buccal aspect of the tooth using periodontal probe of University of North Carolina UNC15 (Medesey®-Italy).
Healing index
score 1 = uneventful healing with no gingival edema, erythema, suppuration, patient discomfort, or flap dehiscence. score 2 = uneventful healing with slight gingival edema, erythema, patient discomfort, or flap dehiscence, but no suppuration. score 3 = poor wound healing with significant gingival edema, erythema, patient discomfort, flap dehiscence, or any suppuration.
Pain index (PI)
Using Visual Analogue scale (VAS) (2001 Crichton), Patients will be asked to select among 100 scores (0 indicating no pain at all , 50 indicating average pain, and 100 indicating very painful).
Patient Perceptions
Using 100 cm Visual Analogue Scale (VAS)Patients will be asked to select among 100 scores (0 indicating very bad, 50 indicating average, and 100 indicating excellent results).
Change in root sensitivity
Using a 100 cm-visual analog scale (VAS), patients' root sensitivity will be recorded with zero indicating no pain or sensitivity, 50 indicating moderate pain or sensitivity and 100 indicating worst pain or sensitivity possible.

Full Information

First Posted
August 28, 2019
Last Updated
January 10, 2021
Sponsor
Damascus University
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1. Study Identification

Unique Protocol Identification Number
NCT04082130
Brief Title
Xenogenic Collagen Matrix and Subepithelial Connective Tissue Graft in the Treatment of Gingival Recession
Official Title
Clinical Comparison of Coronally-advanced Flap Plus Xenogeneic Collagen Matrix (Fibro-Gide®) and Subepithelial Connective Tissue Graft in the Treatment of Gingival Recessions
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
August 25, 2019 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
August 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damascus University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
this study is a Clinical evaluation of using Xenogenic collagen matrix (XCM) plus coronally advanced flap (CAF) compared to subepithelial connective tissue graft (SCTG) plus coronally advanced flap to treat Miller class I gingival recession. A split-full-split thickness flap will be elevated in the (XCM+CAF) group while it will be an only partial thickness flap in the (SCTG+CAF) group. The sample size will be 15 patients. Each patient has bilateral Miller Class I gingival recessions; and as a split-mouth study design one side will be treated with (SCTG+CAF), while the other will be treated with (XCM+CAF).
Detailed Description
The aim of this study is to clinically compare between the subepithelial connective tissue graft (SCTG) plus coronally advanced flap (CAF) which is defined as the golden standard for the treatment of gingival recessions and Xenogenic collagen matrix (XCM) plus coronally advanced flap (CAF) to treat class I Miller gingival recession. CAF elevation will be done as it described by (De Sanctis & Zucchelli 2007) with modifications in the the control group.The flap will be partially elevated in the (SCTG+CAF) group while it will be a split-full-split thickness flap in the (XCM+CAF) group, and finally the flap will stabilized coronally. Fifteen patients who have bilateral buccal Miller Class I gingival recession defects will be enrolled in this study. These defects will be distributed randomly into two groups: the test group (XCM+CAF) and control group (SCTG+CAF). Clinical parameters will be evaluated: Recession depth (REC), change in visible plaque index, recession width (RW), width of keratinized tissue (KT), thickness of gingival tissue (GT), probing depth (PD), clinical attachment level (CAL), healing index (HI), questionnaires will be given to evaluate each of patient perceptions, pain index (PI), and changes in root sensitivity by using visual analog scale (VAS).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession Localized Moderate
Keywords
Xenogenic collagen matrix (XCM)., subepithelial connective tissue graft (SCGT)., coronally advanced flap (CAF)., Root coverage.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
split-mouth design.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
(XCM)+(CAF)
Arm Type
Experimental
Arm Description
Surgical protocol for test treatment with CAF + XCM: After local anesthetizing the recipient site,CAF elevation will be done using (De Sanctis & Zucchelli 2007) design.Horizontal incisions will be done at the recession site,another two slightly divergent vertical incisions will be done at the end of previous incisions extending to the mucogingival junction.The resulting flap will be split thickness in the surgical papillae area,then will be full thickness exposing 3-4 mm of the bone apically of the dehiscence and after that it will be split thickness in the apical direction,all the muscle insertions will be eliminated,the root surface will be prepared by curettes and chemically treated with 24% EDTA gel.De-epithelialization of the interdental papillae will be done.The XCM will be trimmed and fix onto the root surface 1-2mm coronally of the CEJ using absorbable sutures,and the flap will be coronally advanced to fully cover the XCM and then sutured to the de-epithelialized papillae.
Arm Title
(SCTG)+(CAF)
Arm Type
Active Comparator
Arm Description
The surgical protocol in the control group will be identical with test group protocol with these exceptions: The entire flap will be elevated as split thickness instead of split-full-split thickness flap. A SCTG harvested from the palate will be used to cover the exposed denuded root surface in lieu of placement of XCM in the test group. And absorbable sutures will be used to stabilize it 2 mm coronally from the CEJ. As in the test group the mucosal flap will coronally advanced to completely cover the SCTG then sutured to the de-epithelialized papillae.
Intervention Type
Procedure
Intervention Name(s)
(XCM)+(CAF)
Intervention Description
The description of this intervention has been already given before.
Intervention Type
Procedure
Intervention Name(s)
(SCTG)+(CAF)
Intervention Description
The description of this intervention has been already given before.
Primary Outcome Measure Information:
Title
Recession depth (REC): (Change in the amount of root coverage)
Description
from the free gingival margin to the cemento-enamel junction at the mid-buccal aspect. Using University of North Carolina periodontal probe UNC15 (Medesey®-Italy).
Time Frame
1)At baseline, 2) 2 weeks post-surgery, 3) At 1 month post-surgery and 4) 3 months post-surgery.
Secondary Outcome Measure Information:
Title
change in visible plaque index:
Description
Score 0 - No plaque Score 1 - Separate flecks of plaque at the cervical margin of the tooth Score 2 - A thin continuous band of plaque at the cervical margin of the tooth Score 3 - A band of plaque wider then 1mm covering less than 1/3rd of the crown of the tooth Score 4 - Plaque covering at least 1/3rd but less than 2/3rd of the crown of the tooth Score 5 - Plaque covering 2/3rd or more of the crown of the tooth
Time Frame
1) baseline, 2) at 2 weeks postoperative,3) 1 month and 4) 3 month postoperative
Title
Recession width (RW)
Description
at the cemento-enamel junction using periodontal probe of University of North Carolina UNC15 (Medesey®-Italy).
Time Frame
1) at baseline, 2) at 2 weeks postoperative, 3) at 1 month postoperative, 4) and at 3 months postoperative.
Title
Width of keratinized tissue (KT)
Description
from the free gingival margin to the mucogingival junction using periodontal probe of University of North Carolina UNC15 (Medesey®-Italy).
Time Frame
1) baseline, 2) 2 weeks postoperative, 3) 1 month postoperative and 4) 3 months postoperative.
Title
Thickness of gingival tissue (GT)
Description
with an injection needle and a silicon marker, at the mid-buccal aspect below the gingival margin.
Time Frame
1) at baseline, and 2) 3 months postoperative.
Title
Probing depth (PD)
Description
the distance between the gingival margin and the bottom of the pocket measured at the mid-buccal aspect of the tooth using periodontal probe of University of North Carolina UNC15 (Medesey®-Italy).
Time Frame
1) at baseline, 2) and 3 months postoperative.
Title
Clinical attachment level (CAL)
Description
distance between the CEJ and the bottom of the pocket measured at the mid-buccal aspect of the tooth using periodontal probe of University of North Carolina UNC15 (Medesey®-Italy).
Time Frame
1) at baseline, 2) at 3 months postoperative.
Title
Healing index
Description
score 1 = uneventful healing with no gingival edema, erythema, suppuration, patient discomfort, or flap dehiscence. score 2 = uneventful healing with slight gingival edema, erythema, patient discomfort, or flap dehiscence, but no suppuration. score 3 = poor wound healing with significant gingival edema, erythema, patient discomfort, flap dehiscence, or any suppuration.
Time Frame
1) at two weeks following surgery and (2) at one month following surgery.
Title
Pain index (PI)
Description
Using Visual Analogue scale (VAS) (2001 Crichton), Patients will be asked to select among 100 scores (0 indicating no pain at all , 50 indicating average pain, and 100 indicating very painful).
Time Frame
1) at 2 hours, 2) 24 hours, 3) 48 hours,4) 72 hours following surgery and 5) at 1-week after surgery.
Title
Patient Perceptions
Description
Using 100 cm Visual Analogue Scale (VAS)Patients will be asked to select among 100 scores (0 indicating very bad, 50 indicating average, and 100 indicating excellent results).
Time Frame
at three months post-surgery.
Title
Change in root sensitivity
Description
Using a 100 cm-visual analog scale (VAS), patients' root sensitivity will be recorded with zero indicating no pain or sensitivity, 50 indicating moderate pain or sensitivity and 100 indicating worst pain or sensitivity possible.
Time Frame
1) at baseline, 2) and at 3 months postoperative.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
47 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Good general health. No contraindications for periodontal surgery. Presence of one localized gingival recession in each side of the maxilla and/or mandible, All recessions will be Class I defects (Miller 1985). The cemento-enamel junction (CEJ) is visible in the defective teeth. All patients demonstrating good plaque control. No previous periodontal surgery in the targeted area. Exclusion Criteria: Smokers. pregnant or nursing patients. history of malignancy, radiotherapy, or chemotherapy. Patients taking medications that affect mucosal healing. Patients with allergy to collagen. Previous participation in a clinical trial. Type-1 diabetes patients. Patient who have diseases that affect connective tissue metabolism.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noor Alhuda Ewaz Ali, DDS
Organizational Affiliation
MSc student in Periodontics, University of Damascus Dental School
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Suleiman Dayoub, DDS MSc PhD
Organizational Affiliation
Professor of Periodontics, University of Damascus Dental School
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mohammad Alharissy, DDS MSc PhD
Organizational Affiliation
Assistant Professor of Periodontics, Academic Staff Member At Wadi International University
Official's Role
Study Director
Facility Information:
Facility Name
Department of Periodontics, University of Damascus Dental School
City
Damascus
ZIP/Postal Code
DM20AM18
Country
Syrian Arab Republic

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30619640
Citation
Kim HJ, Chang H, Kim S, Seol YJ, Kim HI. Periodontal biotype modification using a volume-stable collagen matrix and autogenous subepithelial connective tissue graft for the treatment of gingival recession: a case series. J Periodontal Implant Sci. 2018 Dec 27;48(6):395-404. doi: 10.5051/jpis.2018.48.6.395. eCollection 2018 Dec.
Results Reference
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Citation
Matoh U, Petelin M, Gaspersic R. Split-Mouth Comparison of Coronally Advanced Flap with Connective Tissue Graft or Collagen Matrix for Treatment of Isolated Gingival Recessions. Int J Periodontics Restorative Dent. 2019 May/Jun;39(3):439-446. doi: 10.11607/prd.3562.
Results Reference
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28304210
Citation
Jepsen K, Stefanini M, Sanz M, Zucchelli G, Jepsen S. Long-Term Stability of Root Coverage by Coronally Advanced Flap Procedures. J Periodontol. 2017 Jul;88(7):626-633. doi: 10.1902/jop.2017.160767. Epub 2017 Mar 17.
Results Reference
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Xenogenic Collagen Matrix and Subepithelial Connective Tissue Graft in the Treatment of Gingival Recession

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