Semilunar and Conventional Coronally Positioned Flap for the Treatment Gingival Recession

Gingival Recession Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03391947
• Other study ID #: UDDS-Perio-01-2018
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: December 20, 2018

Study information

• Verified date: July 2019
• Source: Damascus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 20, 2018
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Gingival Recession
• Root Coverage

Intervention

Procedure:
• semilunar coronally positioned flap
The description of this intervention has been already given before
• coronally advanced flap
The description of this intervention has been already given before

Locations

Country	Name	City	State
Syrian Arab Republic	Department of Periodontics, University of Damascus Dental School	Damascus

Sponsors (1)

Lead Sponsor	Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (10)

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. — View 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. — View 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. — View Citation

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in visible plaque index	Score 0 - No plaque Score 1 - Separate flecks of plaque at the cervical margin of the tooth Score 2 - A thin continuous band of plaque at the cervical margin of the tooth Score 3 - A band of plaque wider then 1mm covering less than 1/3rd of the crown of the tooth Score 4 - Plaque covering at least 1/3rd but less than 2/3rd of the crown of the tooth Score 5 - Plaque covering 2/3rd or more of the crown of the tooth	(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	Change in sulcus bleeding index	will be evaluated visually (using an UNC-15 mm "University of North Carolina" periodontal probe) Score 0 - health looking papillary and marginal gingiva no bleeding on probing; Score 1 - healthy looking gingiva, bleeding on probing; Score 2 - bleeding on probing, change in color, no edema; Score 3 - bleeding on probing, change in color, slight edema; Score 4 -bleeding on probing, change in color, obvious edema; Score 5 -spontaneous bleeding, change in color, marked edema	(1) one day before the surgery, (2) and at 3 months post-surgery
Secondary	Change in probing depth	Probing depth will be measured as the distance from the gingival margin GM to the bottom of the gingival sulcus by using a periodontal probe (UNC 15 "University of North Carolina") with a rubber stopper.	(1) one day before the surgery, (2) and at 3 months post-surgery
Secondary	Change in the clinical attachment level	clinical attachment level will be calculated as the sum of the gingival recession height and the probing depth (mentioned above).	(1) one day before the surgery, (2) and at 3 months post-surgery
Secondary	Change in the gingival recession width	Gingival recession width will be measured from one border of the recession to another at the CEJ 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	(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	Change in the width of keratinized tissue	The width of the keratinized tissue will be measured as the distance between the most apical point of the GM and the MGJ 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.	(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	Change in the thickness of the keratinized tissue		(1) one day before the surgery, (2) and at 3 months post-surgery
Secondary	Change in the position of the mucogingival junction	The distance between the incisal edge and the mucogingival junction will be measured 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	(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	Change in the wound healing index	Wound healing index will be recorded after surgery using the following criteria: score 1 = uneventful healing with no gingival edema, erythema, suppuration, patient discomfort, or flap dehiscence score 2 = uneventful healing with slight gingival edema, erythema, patient discomfort, or flap dehiscence, but no suppuration score 3 = poor wound healing with significant gingival edema, erythema, patient discomfort, flap dehiscence, or any suppuration	(1) at two weeks following surgery and (2) at one month following surgery.
Secondary	Change in post-operative pain level	Using a 10 cm-visual analog scale	at 2 hours, 24 hours, 48 hours, 72 hours following surgery and at 1-week after surgery
Secondary	Patients' satisfaction with aesthetics	Using a 10 cm-visual analog scale (VAS), patients' satisfaction with the aesthetic result will be recorded with 0 indicating very bad, 5 indicating average feelings and 10 indicating excellent result.	at three months post-surgery
Secondary	Change in root sensitivity	Using a 10 cm-visual analog scale (VAS), patients' perception of root sensitivity will be recorded with zero indicating no pain or sensitivity, 5 indicating moderate pain or sensitivity and 10 indicating worst pain or sensitivity possible.	(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