Semilunar and Conventional Coronally Positioned Flap for the Treatment Gingival Recession

NCT ID: NCT03391947

Last Updated: 2019-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2018-12-20

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.

Conditions

Gingival Recession; Root Coverage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

semilunar coronally positioned flap

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.

Group Type: EXPERIMENTAL

semilunar coronally positioned flap

Intervention Type: PROCEDURE

The description of this intervention has been already given before

coronally advanced flap

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.

Group Type: ACTIVE_COMPARATOR

coronally advanced flap

Intervention Type: PROCEDURE

The description of this intervention has been already given before

Interventions

semilunar coronally positioned flap

The description of this intervention has been already given before

Intervention Type: PROCEDURE

coronally advanced flap

The description of this intervention has been already given before

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Damascus University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hala Mohammad Walid Hala Mohammad Walid, DDS

Role: PRINCIPAL_INVESTIGATOR

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

Suleiman Dayoub, DDS MSc PhD

Role: STUDY_CHAIR

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

Locations

Department of Periodontics, University of Damascus Dental School

Damascus, , Syria

Countries

Syria

References

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.

Reference Type: BACKGROUND

PMID: 20528963 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16460241 (View on PubMed)

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.

Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

PMID: 26888240 (View on PubMed)

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.

Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

PMID: 23725027 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10505810 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16253095 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19335093 (View on PubMed)

Other Identifiers

UDDS-Perio-01-2018

Identifier Type: -

Identifier Source: org_study_id