Clinical trial NCT03391947: Semilunar and Conventional Coronally Positioned Flap for the Treatment Gingival Recession
Official title: Comparison of a Semilunar Coronally Positioned Flap and Conventional Coronally Advanced Flap for the Treatment of Gingival Recession- A Split-mouth, Randomized Prospective Comparative Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Root Coverage
Keywords: gingival recession
semilunar coronally flap
coronally advanced flap
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2018-01-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Split-mouth design, i.e. the right side will receive the first intervention, whereas the other side (the left side) will receive the second intervention.
Primary purpose: TREATMENT

Brief summary: A clinical evaluation of using the semilunar coronally position flap (SCPF) compared to the conventional coronally advanced flap (CAF) with modification to treat class I Miller gingival recession. The coronally repositioned gingival margin will be stabilized by coronally anchored suture with composite stops on the buccal surface of the tooth using flowable composite. The sample size will be ten patients. Each patient has bilateral Miller Class I gingival recessions; one will be treated with SCPF, while the other will be treated with CAF

Detailed description: The aim of this study is to clinically compare between the semilunar coronally positioned flap (SCPF) and the conventional coronally advanced flap (CAF) after applying modification in both techniques to treat class I Miller gingival recession. Coronally repositioned gingival margin will be stabilized by coronally anchored suture with composite stops on the buccal surface of tooth using flowable composite for the treatment of gingival recession. Ten patients who have bilateral maxillary buccal Miller Class I gingival recession defects will be enrolled in this study. These defects will be distributed randomly into two groups: the test group (SCPF) and control group (CAF). Clinical parameters will be evaluated: visible plaque index (VPI), sulcus bleeding index (SBI), probing depth (PD), gingival recession height (GRH), gingival recession width (GRW), clinical attachment level (CAL), width of keratinized tissue (WKT), thickness of keratinized tissue (TKT), change in the position of muco-gingival junction, vestibular depth, wound healing index (WHI), the percentage of root coverage (RC) and root coverage esthetic score (RES) system. A questionnaire will be given to each patient, which includes evaluation of the pain intensity, root sensitivity, and satisfaction with aesthetic by using the visual analog scale (VAS) and questions about the number of analgesic pills consumed per day.

Eligibility criteria: Inclusion Criteria:

* Patients are in general good health.
* The patient is non-smoker (less than 10 cigarettes per day) and non-alcoholic.
* Female participants must not be pregnant and not at menstrual period during surgery.
* The patient is committed to the oral care, and has a healthy periodontium.
* Absence of severe oral habits.
* They have not taken medication known to interfere with periodontal tissue health or healing in the preceding 6 months.
* Presence of bilateral buccal Miller class I gingival recessions (≤5 mm) in maxillary incisors, canines, or premolars.
* Presence width of keratinized tissue (WKT) ≥2 mm.
* The tooth is vital and absence of caries or restorations in the areas that will be treated.
* Pocket depth less than 3 mm without bleeding on probing (BOP).

Exclusion Criteria:

1. Patients less than 18 years old
2. Patients with untreated periodontal disease.
3. Smokers.
4. Immunosuppressive systemic diseases (like cancer, AIDS, diabetes...)
5. Miller's class II, III or IV gingival recession defects.
6. Presence of apical radiolucency or root surface restoration or caries at the defect site
7. Medications influence on the health of the gingival tissue (like calcium channel blockers, immunosuppressive systemic diseases (like cancer, AIDS, diabetes...) or Long-term steroid use

Primary outcomes:
measure: Change in the amount of root coverage
timeFrame: (1) one day before the surgery, (2) at 2 weeks post-surgery, (3) at 1 month post-surgery, (4) and at 3 months post-surgery
Secondary outcomes:
measure: Change in visible plaque index
timeFrame: (1) one day before the surgery, (2) at 2 weeks post-surgery, (3) at 1 month post-surgery, (4) and at 3 months post-surgery
measure: Change in sulcus bleeding index
timeFrame: (1) one day before the surgery, (2) and at 3 months post-surgery
measure: Change in probing depth
timeFrame: (1) one day before the surgery, (2) and at 3 months post-surgery
measure: Change in the clinical attachment level
timeFrame: (1) one day before the surgery, (2) and at 3 months post-surgery
measure: Change in the gingival recession width
timeFrame: (1) one day before the surgery, (2) at 2 weeks post-surgery, (3) at 1 month post-surgery, (4) and at 3 months post-surgery
measure: Change in the width of keratinized tissue
timeFrame: (1) one day before the surgery, (2) at 2 weeks post-surgery, (3) at 1 month post-surgery, (4) and at 3 months post-surgery
measure: Change in the thickness of the keratinized tissue
timeFrame: (1) one day before the surgery, (2) and at 3 months post-surgery
measure: Change in the position of the mucogingival junction
timeFrame: (1) one day before the surgery, (2) at 2 weeks post-surgery, (3) at 1 month post-surgery, (4) and at 3 months post-surgery
measure: Change in the wound healing index
timeFrame: (1) at two weeks following surgery and (2) at one month following surgery.
measure: Change in post-operative pain level
timeFrame: at 2 hours, 24 hours, 48 hours, 72 hours following surgery and at 1-week after surgery
measure: Patients' satisfaction with aesthetics
timeFrame: at three months post-surgery
measure: Change in root sensitivity
timeFrame: (1) one day before the surgery, (2) at 2 weeks post-surgery, (3) at 1 month post-surgery, (4) and at 3 months post-surgery
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Department of Periodontics, University of Damascus Dental School
Study officials:
affiliation: MSc student in Periodontics, Periodontology Department, University of Damascus Dental School
name: Hala Mohammad Walid Hala Mohammad Walid, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of Periodontics, Department of Periodontology, University of Damascus Dental School
name: Suleiman Dayoub, DDS MSc PhD
role: STUDY_CHAIR
References:
citation: Santana RB, Mattos CM, Dibart S. A clinical comparison of two flap designs for coronal advancement of the gingival margin: semilunar versus coronally advanced flap. J Clin Periodontol. 2010 Jul;37(7):651-8. doi: 10.1111/j.1600-051X.2010.01582.x. Epub 2010 Jun 1.
citation: Bittencourt S, Del Peloso Ribeiro E, Sallum EA, Sallum AW, Nociti FH Jr, Casati MZ. Comparative 6-month clinical study of a semilunar coronally positioned flap and subepithelial connective tissue graft for the treatment of gingival recession. J Periodontol. 2006 Feb;77(2):174-81. doi: 10.1902/jop.2006.050114.
citation: Bittencourt S, Ribeiro Edel P, Sallum EA, Sallum AW, Nociti FH Jr, Casati MZ. Root surface biomodification with EDTA for the treatment of gingival recession with a semilunar coronally repositioned flap. J Periodontol. 2007 Sep;78(9):1695-701. doi: 10.1902/jop.2007.060507.
citation: Bhandari R, Uppal RS, Kahlon KS. Comparison of semilunar coronally advanced flap alone and in combination with button technique in the treatment of Miller's Class I and II gingival recessions: A pilot study. Indian J Dent Res. 2015 Nov-Dec;26(6):609-12. doi: 10.4103/0970-9290.176925.
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citation: Ozcelik O, Haytac MC, Seydaoglu G. Treatment of multiple gingival recessions using a coronally advanced flap procedure combined with button application. J Clin Periodontol. 2011 Jun;38(6):572-80. doi: 10.1111/j.1600-051X.2011.01724.x. Epub 2011 Mar 28.
citation: Kaval B, Renaud DE, Scott DA, Buduneli N. The role of smoking and gingival crevicular fluid markers on coronally advanced flap outcomes. J Periodontol. 2014 Mar;85(3):395-405. doi: 10.1902/jop.2013.120685. Epub 2013 May 31.
citation: Pini-Prato G, Baldi C, Pagliaro U, Nieri M, Saletta D, Rotundo R, Cortellini P. Coronally advanced flap procedure for root coverage. Treatment of root surface: root planning versus polishing. J Periodontol. 1999 Sep;70(9):1064-76. doi: 10.1902/jop.1999.70.9.1064.
citation: Huang LH, Neiva RE, Wang HL. Factors affecting the outcomes of coronally advanced flap root coverage procedure. J Periodontol. 2005 Oct;76(10):1729-34. doi: 10.1902/jop.2005.76.10.1729.
citation: Cairo F, Rotundo R, Miller PD, Pini Prato GP. Root coverage esthetic score: a system to evaluate the esthetic outcome of the treatment of gingival recession through evaluation of clinical cases. J Periodontol. 2009 Apr;80(4):705-10. doi: 10.1902/jop.2009.080565.