Semilunar and Conventional Coronally Positioned Flap for the Treatment Gingival Recession

NCT03391947 | Completed DMC

• 1 other identifier: UDDS-Perio-01-2018
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Gingival Recession; Root Coverage

Keywords

gingival recession; semilunar coronally flap; coronally advanced flap

Outcome Measures

Primary Outcomes (1)

• Change in the amount of root coverage

  this will be measured as a change of gingival recession height GRH (the distance from the cemento-enamel junction CEJ to the gingival margin GM by using an endodontic finger spreader attached to a rubber stopper and after removing the spreader, penetration depth was measured with a caliper of 0.01-mm resolution) from baseline and follow-up period.

  (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 (12)

• Change in visible plaque index

  (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

• Change in sulcus bleeding index

  (1) one day before the surgery, (2) and at 3 months post-surgery

• Change in probing depth

  (1) one day before the surgery, (2) and at 3 months post-surgery

• Change in the clinical attachment level

  (1) one day before the surgery, (2) and at 3 months post-surgery

• Change in the gingival recession width

  (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

Study Arms (2)

semilunar coronally positioned flap

EXPERIMENTAL

A semilunar incision will be done following the curvature of the gingival margin and ending about 2 to 3 mm short of the tip of the papillae. The most apical distance of this incision to the gingival margin will be obtained by adding the bone sounding measurement to the recession height. Perform a split-thickness dissection coronally from the incision, and connect it to an intrasulcular incision. The tissue will be collapsed coronally, covering the denuded root. 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. Finally, the area will be covered with a periodontal dressing. This is called semilunar coronally positioned flap.

Procedure: semilunar coronally positioned flap

coronally advanced flap

ACTIVE COMPARATOR

Coronally positioned flap will be initiated with two vertical incisions, extending from a mesial and distal linear angle at the cementoenamel junction (CEJ) and go beyond the mucogingival junction. A split thickness flap will be prepared by sharp dissection mesial and distal to the recession and connected with an intra crevicular incision. On the facial aspect of the tooth, a full thickness flap, approximately 3-4 mm apical to crest of alveolar bone. Then, the flap will be returned and sutured it at 1 mm coronal to the CEJ after de-epithelize the papillae. 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 and sutured in the papilla region and releasing incision. Finally, the area will be covered with a periodontal dressing.

Procedure: coronally advanced flap

Interventions

semilunar coronally positioned flap PROCEDURE

The description of this intervention has been already given before

semilunar coronally positioned flap

coronally advanced flap PROCEDURE

The description of this intervention has been already given before

coronally advanced flap

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• Patients less than 18 years old
• Patients with untreated periodontal disease.
• Smokers.
• Immunosuppressive systemic diseases (like cancer, AIDS, diabetes…)
• Miller's class II, III or IV gingival recession defects.
• Presence of apical radiolucency or root surface restoration or caries at the defect site
• 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

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Department of Periodontics, University of Damascus Dental School

Damascus, DM20AM18, Syria

Location

Related Publications (10)

• 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.

  PMID: 20528963 BACKGROUND

• 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.

  PMID: 16460241 BACKGROUND

• 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.

  PMID: 17760538 BACKGROUND

• 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.

  PMID: 26888240 BACKGROUND

• Bittencourt S, Ribeiro Edel P, Sallum EA, Sallum AW, Nociti FH, Casati MZ. Semilunar coronally positioned flap or subepithelial connective tissue graft for the treatment of gingival recession: a 30-month follow-up study. J Periodontol. 2009 Jul;80(7):1076-82. doi: 10.1902/jop.2009.080498.

  PMID: 19563287 BACKGROUND

• 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.

  PMID: 21443557 BACKGROUND

• 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.

  PMID: 23725027 BACKGROUND

• 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.

  PMID: 10505810 BACKGROUND

• 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.

  PMID: 16253095 BACKGROUND

• 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.

  PMID: 19335093 BACKGROUND

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• Hala Mohammad Walid Hala Mohammad Walid, DDS

  MSc student in Periodontics, Periodontology Department, University of Damascus Dental School

  PRINCIPAL INVESTIGATOR

• Suleiman Dayoub, DDS MSc PhD

  Professor of Periodontics, Department of Periodontology, University of Damascus Dental School

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 31, 2017
• First Posted: January 5, 2018
• Study Start: December 1, 2017
• Primary Completion: August 1, 2018
• Study Completion: December 20, 2018
• Last Updated: July 18, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)