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Soft Tissue Augmentation Using Deepithelialized Free Gingival Graft Compared to Connective Tissue Graft in Management of Miller Class I and II Gingival Recession.

Primary Purpose

Gingival Recession

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Coronally advanced flap and subepithelial connective tissue graft
Coronally advanced flap and deepithelialized free gingival graft
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession focused on measuring gingival recession, connective tissue graft, deepithelialized free gingival graft, free gingival graft

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Patients 18 years or older.
  2. Periodontally and systemically healthy.
  3. Buccal recession defects classified as either Miller class I or II.
  4. Presence of identifiable Cementoenamel juction (Zucchelli et al., 2010).
  5. Clinical indication and/or patient request for recession coverage.
  6. O'Leary index less than 20% (O'Leary et al., 1972).

Exclusion Criteria:

  1. Miller class III or IV recession defects.
  2. Pregnant females.
  3. Smokers as smoking is a contraindication for any plastic periodontal surgery (Khuller, 2009).
  4. Handicapped and mentally retarded patients.
  5. Patients undergoing radiotherapy.
  6. Teeth with cervical restorations, abrasion.
  7. Presence of systemic disease that would affect wound healing.

Sites / Locations

  • Faculty of Oral and Dental Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Subepithelial connective tissue graft

De-epithelialized free gingival graft

Arm Description

Patients will receive a coronally advanced flap surgery with a subepithelial connective tissue graft for recession coverage.

Patients will receive a coronally advanced flap surgery with a de-epithelialized free gingival graft for recession coverage.

Outcomes

Primary Outcome Measures

Gingival Thickness
Thickness of the gingival tissues 2 mm from the free gingival margin

Secondary Outcome Measures

Percentage of root coverage
(Preoperative vertical recession - Postoperative vertical recession/preoperative vertical recession) x 100.
Root coverage esthetic score
A system proposed for evaluating esthetic outcomes of root coverage procedures.
Post-Operative Pain
Visual Analogue Scale (VAS) with numbers from 0 to 10 ('no pain' to 'worst pain imaginable') measured daily for the first 2 weeks postoperatively
Post-operative stress
level of stress experienced by the patients of jeopardizing the palatal wound during the time of healing
Post-operative bleeding
prolonged hemorrhaging during the post-surgical week reported by the patients measured by a questionnaire as a categorical yes or no question.
Post-operative inability to chew
Will be described as the level of variation of the patient's eating habits due to the presence of the palatal wound.
Post-Surgical Patient Satisfaction
A 3-item questionnaire is asked and the patients shall use a 7-point answer scale.

Full Information

First Posted
July 6, 2017
Last Updated
August 11, 2019
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03213483
Brief Title
Soft Tissue Augmentation Using Deepithelialized Free Gingival Graft Compared to Connective Tissue Graft in Management of Miller Class I and II Gingival Recession.
Official Title
Soft Tissue Augmentation Using Deepithelialized Free Gingival Graft Compared to Connective Tissue Graft in Management of Miller Class I and II Gingival Recession. A Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
October 17, 2017 (Actual)
Primary Completion Date
May 27, 2019 (Actual)
Study Completion Date
July 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo 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
The aim of this study will be to clinically assess the soft tissue augmentation achieved by the de-epithelialized free gingival graft with coronally advanced flap versus the subepithelial connective tissue graft with coronally advanced flap as root coverage procedures for management of patients with Miller class I and II gingival recession.
Detailed Description
Evidence from the literature showed that coronally advanced flap was a predictable method for root coverage. The addition of a connective tissue graft was also found to improve the outcome of obtaining complete root coverage in Miller class I and II gingival recession. Many different connective tissue graft-harvesting techniques have been utilized. These techniques aimed at reducing patient morbidity by primary closure of the palatal flap to achieve primary intention wound healing. However, they had the limitation of requiring an adequate thickness of the palatal fibromucosa in order to prevent desquamation of the undermined flap and compromised vasculature. On the other hand, the free gingival graft surgical technique was also unaccepted esthetically due to the white scar and irregularities produced at the monolingual junction. Moreover, despite the fact that the free gingival graft had its limitation of being associated with greater post-operative pain, discomfort and bleeding due to healing by secondary intention in 2-4 weeks, nevertheless, this technique was much easier to perform and could be used even in cases of thin palatal fibromucosa. The evidence in literature comparing patient morbidity and root coverage outcomes between these two techniques is minimal. Studies by Griffin et al. (2006) and Wessel and Tatakis (2008) reported increased incidence of post-operative pain with free gingival grafts. However, a recently study by Zucchelli et al. (2010) compared post-operative morbidity and root coverage outcomes in patients treated with trap-door connective tissue graft and de-epithelialized free gingival graft found no statistically significant differences in pain killer consumption, post-operative discomfort and bleeding between the two groups. Still very few studies measured the effect of different connective tissue graft harvesting techniques on gingival thickness. And even in the study by Zucchelli et al. (2010), only speculative explanation was given regarding the increase of gingival thickness in case of a de-epithelialized free gingival graft than subepithelial connective tissue graft. Gingival thickness was proved to be an important factor for the etiology of gingival recession as thick gingival tissues are able to confine the inflammation within the region of the gingival sulcus and prevent its extension to destroy the outer gingival tissue leading to gingival recession. Therefore, this study will monitor the effect of different connective tissue harvesting techniques (De-epithelialized free gingival graft versus subepithelial connective tissue graft) on gingival thickness enhancement. It will also evaluate the de-epithelialized free gingival graft as a harvesting mechanism for connective tissue graft in terms of patient morbidity and root coverage outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession
Keywords
gingival recession, connective tissue graft, deepithelialized free gingival graft, free gingival graft

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel groups, randomized clinical trial
Masking
Care ProviderOutcomes Assessor
Masking Description
Single blinded: Blinding of the participants is not applicable. Blinding of the operator is not applicable. Outcome assessor (primary and secondary outcomes) & biostatistician will be blinded.
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Subepithelial connective tissue graft
Arm Type
Active Comparator
Arm Description
Patients will receive a coronally advanced flap surgery with a subepithelial connective tissue graft for recession coverage.
Arm Title
De-epithelialized free gingival graft
Arm Type
Experimental
Arm Description
Patients will receive a coronally advanced flap surgery with a de-epithelialized free gingival graft for recession coverage.
Intervention Type
Procedure
Intervention Name(s)
Coronally advanced flap and subepithelial connective tissue graft
Intervention Description
The connective tissue graft is obtained by a single line incision from the palate.
Intervention Type
Procedure
Intervention Name(s)
Coronally advanced flap and deepithelialized free gingival graft
Intervention Description
The connective tissue graft is obtained by deepithelialization of a free gingival graft.
Primary Outcome Measure Information:
Title
Gingival Thickness
Description
Thickness of the gingival tissues 2 mm from the free gingival margin
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Percentage of root coverage
Description
(Preoperative vertical recession - Postoperative vertical recession/preoperative vertical recession) x 100.
Time Frame
6 months
Title
Root coverage esthetic score
Description
A system proposed for evaluating esthetic outcomes of root coverage procedures.
Time Frame
6 months
Title
Post-Operative Pain
Description
Visual Analogue Scale (VAS) with numbers from 0 to 10 ('no pain' to 'worst pain imaginable') measured daily for the first 2 weeks postoperatively
Time Frame
Two weeks
Title
Post-operative stress
Description
level of stress experienced by the patients of jeopardizing the palatal wound during the time of healing
Time Frame
Two weeks
Title
Post-operative bleeding
Description
prolonged hemorrhaging during the post-surgical week reported by the patients measured by a questionnaire as a categorical yes or no question.
Time Frame
Two weeks
Title
Post-operative inability to chew
Description
Will be described as the level of variation of the patient's eating habits due to the presence of the palatal wound.
Time Frame
Two weeks
Title
Post-Surgical Patient Satisfaction
Description
A 3-item questionnaire is asked and the patients shall use a 7-point answer scale.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients 18 years or older. Periodontally and systemically healthy. Buccal recession defects classified as either Miller class I or II. Presence of identifiable Cementoenamel juction (Zucchelli et al., 2010). Clinical indication and/or patient request for recession coverage. O'Leary index less than 20% (O'Leary et al., 1972). Exclusion Criteria: Miller class III or IV recession defects. Pregnant females. Smokers as smoking is a contraindication for any plastic periodontal surgery (Khuller, 2009). Handicapped and mentally retarded patients. Patients undergoing radiotherapy. Teeth with cervical restorations, abrasion. Presence of systemic disease that would affect wound healing.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Azza Ezz Elarab, Phd
Organizational Affiliation
Professor
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Noha Ghallab, Phd
Organizational Affiliation
Professor
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Weam El Battawy, Phd
Organizational Affiliation
Lecturer
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Oral and Dental Medicine
City
Cairo
ZIP/Postal Code
12114
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20590963
Citation
Zucchelli G, Mele M, Stefanini M, Mazzotti C, Marzadori M, Montebugnoli L, de Sanctis M. Patient morbidity and root coverage outcome after subepithelial connective tissue and de-epithelialized grafts: a comparative randomized-controlled clinical trial. J Clin Periodontol. 2010 Aug 1;37(8):728-38. doi: 10.1111/j.1600-051X.2010.01550.x. Epub 2010 Jun 24.
Results Reference
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Soft Tissue Augmentation Using Deepithelialized Free Gingival Graft Compared to Connective Tissue Graft in Management of Miller Class I and II Gingival Recession.

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