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

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

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.

Study Overview

• Status: Completed
• Conditions: Gingival Recession
• Intervention / Treatment: Procedure: Coronally advanced flap and subepithelial connective tissue graft; Procedure: Coronally advanced flap and deepithelialized free gingival graft

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 12114
    • Faculty of Oral and Dental Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Subepithelial connective tissue graft; Patients will receive a coronally advanced flap surgery with a subepithelial connective tissue graft for recession coverage.	Procedure: Coronally advanced flap and subepithelial connective tissue graft; The connective tissue graft is obtained by a single line incision from the palate.
EXPERIMENTAL: De-epithelialized free gingival graft; Patients will receive a coronally advanced flap surgery with a de-epithelialized free gingival graft for recession coverage.	Procedure: Coronally advanced flap and deepithelialized free gingival graft; The connective tissue graft is obtained by deepithelialization of a free gingival graft.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gingival Thickness	Thickness of the gingival tissues 2 mm from the free gingival margin	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of root coverage	(Preoperative vertical recession - Postoperative vertical recession/preoperative vertical recession) x 100.	6 months
Post-Surgical Patient Satisfaction	A 3-item questionnaire is asked and the patients shall use a 7-point answer scale.	6 months
Root coverage esthetic score	A system proposed for evaluating esthetic outcomes of root coverage procedures.	6 months
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	Two weeks
Post-operative stress	level of stress experienced by the patients of jeopardizing the palatal wound during the time of healing	Two weeks
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.	Two weeks
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.	Two weeks

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Azza Ezz Elarab, Phd, Professor; Study Director: Noha Ghallab, Phd, Professor; Study Director: Weam El Battawy, Phd, lecturer

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 17, 2017
• Primary Completion (ACTUAL): May 27, 2019
• Study Completion (ACTUAL): July 27, 2019

Study Registration Dates

• First Submitted: July 6, 2017
• First Submitted That Met QC Criteria: July 7, 2017
• First Posted (ACTUAL): July 11, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 13, 2019
• Last Update Submitted That Met QC Criteria: August 11, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: gingival recession; connective tissue graft; free gingival graft; deepithelialized free gingival graft
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: Deepfggvsctg

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No