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.
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
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Keywords: gingival recession
connective tissue graft
deepithelialized free gingival graft
free gingival graft
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-07-11
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel groups, randomized clinical trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Gingival Thickness
timeFrame: 6 months
Secondary outcomes:
measure: Percentage of root coverage
timeFrame: 6 months
measure: Root coverage esthetic score
timeFrame: 6 months
measure: Post-Operative Pain
timeFrame: Two weeks
measure: Post-operative stress
timeFrame: Two weeks
measure: Post-operative bleeding
timeFrame: Two weeks
measure: Post-operative inability to chew
timeFrame: Two weeks
measure: Post-Surgical Patient Satisfaction
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Oral and Dental Medicine
Study officials:
affiliation: Professor
name: Azza Ezz Elarab, Phd
role: STUDY_CHAIR
affiliation: Professor
name: Noha Ghallab, Phd
role: STUDY_DIRECTOR
affiliation: Lecturer
name: Weam El Battawy, Phd
role: STUDY_DIRECTOR
References:
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.