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Gingival Recession Treatment Using Two Different Surgical Techniques

Primary Purpose

Gingival Recession, Root Planing

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

xenogeneic collagen matrix

About this trial

This is an interventional treatment trial for Gingival Recession focused on measuring root coverage, mucoderm, connective tissue, grafts

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

-The selected patients for this study are non-smokers, aged 18-60 years with multiple gingival recession (Miller class 1, or 2.) for more than two adjacent affected teeth with plaque score less than 25%

Exclusion Criteria:

-Patients with systemic complications, psychological problems, parafunctional habits, or patients presented with Mal-posed teeth, hypermobile teeth, teeth with Miller class 3 gingival recession were excluded from this study.

Sites / Locations

Assiut University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

root coverage surgeries using autologous connective tissue for treatment of gingival recession

root coverage surgeries using xenogenic collagen matrix for treatment of gingival recession

Arm Description

root coverage surgeries using tunneling technique of autologous connective tissue as a treatment of Miller class two gingival recession

root coverage surgeries using tunneling technique of mucodrm membrane ; xenogeneic collagen matrix as a treatment of Miller class two gingival recession

Outcomes

Primary Outcome Measures

The zone of keratinized gingiva

The distance from the tip of the papilla to the mucogingival junction minus the probing depth measured in mm using graduated periodontal probe.

Secondary Outcome Measures

Periodontal probing depth

measured from the gingival margin to the depth of the gingival sulcus in six sites per tooth and measured in mm.

Clinical attachment loss

measured from the cementoenamel junction to the depth of the sulcus in six sites per tooth and measured in mm.

Gingival recession

The depth measured from the gingival margin to the cementoenamel junction in mm.

Patient satisfaction of the esthetics

measured using the visual analog scale.

Full Information

NCT ID

NCT04966208

First Posted

June 21, 2021

Last Updated

July 7, 2021

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT04966208

Brief Title

Gingival Recession Treatment Using Two Different Surgical Techniques

Official Title

Root Coverage Using Tunneling Technique of Xenogenic Collagen Matrix vs. Autologous Connective Tissue as a Treatment of Miller Class Two Gingival Recession (RCT Study)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

September 1, 2020 (Actual)

Primary Completion Date

March 1, 2021 (Actual)

Study Completion Date

June 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Coronally the advanced flap is considered a predictable treatment of gingival recession but in certain situations, it needs a filler like subperiosteal connective tissue graft (CTG) which is considered as the gold standard treatment approach. This randomized controlled trial compares the clinical benefits and effectiveness of a xenogenic collagen matrix (mucoderm, botiss, dental, Berlin, Germany) as a filler to the subperiosteal connective tissue graft (CTG).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gingival Recession, Root Planing

Keywords

root coverage, mucoderm, connective tissue, grafts

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

root coverage surgeries using autologous connective tissue for treatment of gingival recession

Arm Type

Active Comparator

Arm Description

root coverage surgeries using tunneling technique of autologous connective tissue as a treatment of Miller class two gingival recession

Arm Title

root coverage surgeries using xenogenic collagen matrix for treatment of gingival recession

Arm Type

Experimental

Arm Description

root coverage surgeries using tunneling technique of mucodrm membrane ; xenogeneic collagen matrix as a treatment of Miller class two gingival recession

Intervention Type

Procedure

Intervention Name(s)

xenogeneic collagen matrix

Intervention Description

xenogeneic collagen matrix called mucoderm used for root coverage for treatment of gingival recession instead of harvesting from the patients connective tissue

Primary Outcome Measure Information:

Title

The zone of keratinized gingiva

Description

The distance from the tip of the papilla to the mucogingival junction minus the probing depth measured in mm using graduated periodontal probe.

Time Frame

6 months after the surgery

Secondary Outcome Measure Information:

Title

Periodontal probing depth

Description

measured from the gingival margin to the depth of the gingival sulcus in six sites per tooth and measured in mm.

Time Frame

6 months after the surgery

Title

Clinical attachment loss

Description

measured from the cementoenamel junction to the depth of the sulcus in six sites per tooth and measured in mm.

Time Frame

6 months after the surgery

Title

Gingival recession

Description

The depth measured from the gingival margin to the cementoenamel junction in mm.

Time Frame

6 months after the surgery

Title

Patient satisfaction of the esthetics

Description

measured using the visual analog scale.

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: -The selected patients for this study are non-smokers, aged 18-60 years with multiple gingival recession (Miller class 1, or 2.) for more than two adjacent affected teeth with plaque score less than 25% Exclusion Criteria: -Patients with systemic complications, psychological problems, parafunctional habits, or patients presented with Mal-posed teeth, hypermobile teeth, teeth with Miller class 3 gingival recession were excluded from this study.

Facility Information:

Facility Name

Assiut University

City

Assuit

ZIP/Postal Code

71111111

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

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Gingival Recession Treatment Using Two Different Surgical Techniques

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