- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03213483
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
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Cairo, Egypt, 12114
- Faculty of Oral and Dental Medicine
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
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.
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The connective tissue graft is obtained by a single line incision from the palate.
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EXPERIMENTAL: De-epithelialized free gingival graft
Patients will receive a coronally advanced flap surgery with a de-epithelialized free gingival graft for recession coverage.
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The connective tissue graft is obtained by deepithelialization of a free gingival graft.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gingival Thickness
Time Frame: 6 months
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Thickness of the gingival tissues 2 mm from the free gingival margin
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of root coverage
Time Frame: 6 months
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(Preoperative vertical recession - Postoperative vertical recession/preoperative vertical recession) x 100.
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6 months
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Post-Surgical Patient Satisfaction
Time Frame: 6 months
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A 3-item questionnaire is asked and the patients shall use a 7-point answer scale.
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6 months
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Root coverage esthetic score
Time Frame: 6 months
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A system proposed for evaluating esthetic outcomes of root coverage procedures.
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6 months
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Post-Operative Pain
Time Frame: Two weeks
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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
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Post-operative stress
Time Frame: Two weeks
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level of stress experienced by the patients of jeopardizing the palatal wound during the time of healing
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Two weeks
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Post-operative bleeding
Time Frame: Two weeks
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prolonged hemorrhaging during the post-surgical week reported by the patients measured by a questionnaire as a categorical yes or no question.
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Two weeks
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Post-operative inability to chew
Time Frame: Two weeks
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Will be described as the level of variation of the patient's eating habits due to the presence of the palatal wound.
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Two weeks
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Collaborators and Investigators
Sponsor
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
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Deepfggvsctg
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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