Clinical trial NCT02656732: Amnion Chorion Membrane in Comparison to Subepithelial Connective Tissue Graft in Gingival Recession Coverage
Official title: Clinical Evaluation of Amnion Chorion Membrane in Comparison to Subepithelial Connective Tissue Graft in Gingival Recession Coverage: A Randomized Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-01-15
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present randomized, controlled, parallel-grouped trial included twenty patients (aged 20 to 54 years) suffering from Miller's class I or II gingival recession. Patients were randomly assigned into two equal groups; control group; the coronally advanced flap with the subepithelial connective tissue graft (CAF+SCTG) or the test group; coronally advanced flap with amnion chorion allograft membrane (CAF+AC).

Detailed description: The participants were randomly assigned to receive coronally advanced flap (CAF) with amnion chorion membrane or CAF with subepithelial connective tissue graft using a simple randomization procedure with a 1:1 allocation ratio. A computer generated randomization list was drawn up by a faculty member who was not involved in the recruitment. Allocation concealment was achieved by sealed coded opaque envelopes that contained the treatment to be performed to the enrolled subjects based on the randomized numbers. Consequently, patients were allocated to either AC membrane (intervention) or SCTG (control) groups. The sealed envelope containing treatment assignment was opened at time of the surgery and the number was picked by another person other than the operator.

Eligibility criteria: Inclusion Criteria:

* Subjects aged between 18 - 60 years old.
* Subjects with facial gingival recession defects in anterior and premolar teeth classified as either class I or II defects according to Miller's classification.
* Subjects able to tolerate surgical periodontal procedures.
* Accepts the 6 months follow-up period.

Exclusion Criteria:

* Current and former smokers.
* Pregnant females.
* Subjects received any periodontal therapy for a minimum of 6 months prior to the study.
* Subjects taking drugs known to interfere with wound healing.
* Subjects with unacceptable oral hygiene with plaque index \>2.
* Teeth with non-carious cervical lesions, cervical caries and malalignment.

Primary outcomes:
measure: recession depth
timeFrame: Change in mm from baseline before surgical procedure to follow up at 6 months.
Secondary outcomes:
measure: Recession Width
timeFrame: Change in mm from baseline before surgical procedure to follow up at 6 months.
measure: Width of keratinized gingiva
timeFrame: Change in mm from baseline before surgical procedure to follow up at 6 months.
measure: Probing pocket depth
timeFrame: Change in mm from baseline before surgical procedure to follow up at 6 months.
measure: Clinical attachment level
timeFrame: Change in mm from baseline before surgical procedure to follow up at 6 months.
measure: Tissue Biotype
timeFrame: Change in mm from baseline before surgical procedure to follow up at 6 months.
measure: root coverage esthetic score
timeFrame: score taken after completion of the study at 6 months
measure: Patient reported outcomes
timeFrame: taken after completion of the study at 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Professor of Oral Medicine and Periodontology, Faculty of Oral and Dental Medicine, Cairo University.
name: Mona Shoeib, MD
role: STUDY_CHAIR
affiliation: Associate Professor of Oral Medicine and Periodontology, Faculty of Oral and Dental Medicine, Cairo University.
name: Hani El-Nahas, MD
role: STUDY_DIRECTOR
affiliation: manarzanaty@hotmail.com
name: Manar El-Zanaty, Msc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cairo F, Cortellini P, Tonetti M, Nieri M, Mervelt J, Cincinelli S, Pini-Prato G. Coronally advanced flap with and without connective tissue graft for the treatment of single maxillary gingival recession with loss of inter-dental attachment. A randomized controlled clinical trial. J Clin Periodontol. 2012 Aug;39(8):760-8. doi: 10.1111/j.1600-051X.2012.01903.x. Epub 2012 May 28.
citation: Cairo F, Nieri M, Pagliaro U. Efficacy of periodontal plastic surgery procedures in the treatment of localized facial gingival recessions. A systematic review. J Clin Periodontol. 2014 Apr;41 Suppl 15:S44-62. doi: 10.1111/jcpe.12182.
citation: Chambrone L, Tatakis DN. Periodontal soft tissue root coverage procedures: a systematic review from the AAP Regeneration Workshop. J Periodontol. 2015 Feb;86(2 Suppl):S8-51. doi: 10.1902/jop.2015.130674.
citation: Chakraborthy S, Sambashivaiah S, Kulal R, Bilchodmath S. Amnion and Chorion Allografts in Combination with Coronally Advanced Flap in the Treatment of Gingival Recession: A Clinical Study. J Clin Diagn Res. 2015 Sep;9(9):ZC98-ZC101. doi: 10.7860/JCDR/2015/12971.6572. Epub 2015 Sep 1.
citation: de Sanctis M, Zucchelli G. Coronally advanced flap: a modified surgical approach for isolated recession-type defects: three-year results. J Clin Periodontol. 2007 Mar;34(3):262-8. doi: 10.1111/j.1600-051X.2006.01039.x.
citation: Ghahroudi AA, Khorsand A, Rokn AR, Sabounchi SS, Shayesteh YS, Soolari A. Comparison of amnion allograft with connective tissue graft for root coverage procedures: a double-blind, randomized, controlled clinical trial. J Int Acad Periodontol. 2013 Oct;15(4):101-12.