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Semilunar and Conventional Coronally Positioned Flap for the Treatment Gingival Recession

Primary Purpose

Gingival Recession, Root Coverage

Status

Completed

Phase

Not Applicable

Locations

Syrian Arab Republic

Study Type

Interventional

Intervention

semilunar coronally positioned flap

coronally advanced flap

About this trial

This is an interventional treatment trial for Gingival Recession focused on measuring gingival recession, semilunar coronally flap, coronally advanced flap

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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:

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

Sites / Locations

Department of Periodontics, University of Damascus Dental School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

semilunar coronally positioned flap

coronally advanced flap

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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

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.

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).

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

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.

Change in the thickness of the keratinized tissue

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

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

Change in post-operative pain level

Using a 10 cm-visual analog scale

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.

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.

Full Information

NCT ID

NCT03391947

First Posted

December 31, 2017

Last Updated

July 16, 2019

Sponsor

Damascus University

1. Study Identification

Unique Protocol Identification Number

NCT03391947

Brief Title

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

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

December 1, 2017 (Actual)

Primary Completion Date

August 1, 2018 (Actual)

Study Completion Date

December 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Damascus University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gingival Recession, Root Coverage

Keywords

gingival recession, semilunar coronally flap, coronally advanced flap

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

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.

Masking

Participant

Allocation

Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

semilunar coronally positioned flap

Arm Type

Experimental

Arm Description

Arm Title

coronally advanced flap

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

semilunar coronally positioned flap

Intervention Description

The description of this intervention has been already given before

Intervention Type

Procedure

Intervention Name(s)

coronally advanced flap

Intervention Description

The description of this intervention has been already given before

Primary Outcome Measure Information:

Title

Change in the amount of root coverage

Description

Time Frame

(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 Outcome Measure Information:

Title

Change in visible plaque index

Description

Time Frame

(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

Title

Change in sulcus bleeding index

Description

Time Frame

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

Title

Change in probing depth

Description

Time Frame

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

Title

Change in the clinical attachment level

Description

clinical attachment level will be calculated as the sum of the gingival recession height and the probing depth (mentioned above).

Time Frame

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

Title

Change in the gingival recession width

Description

Time Frame

(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

Title

Change in the width of keratinized tissue

Description

Time Frame

(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

Title

Change in the thickness of the keratinized tissue

Time Frame

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

Title

Change in the position of the mucogingival junction

Description

Time Frame

(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

Title

Change in the wound healing index

Description

Time Frame

(1) at two weeks following surgery and (2) at one month following surgery.

Title

Change in post-operative pain level

Description

Using a 10 cm-visual analog scale

Time Frame

at 2 hours, 24 hours, 48 hours, 72 hours following surgery and at 1-week after surgery

Title

Patients' satisfaction with aesthetics

Description

Time Frame

at three months post-surgery

Title

Change in root sensitivity

Description

Time Frame

(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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hala Mohammad Walid Hala Mohammad Walid, DDS

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Suleiman Dayoub, DDS MSc PhD

Organizational Affiliation

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

Official's Role

Study Chair

Facility Information:

Facility Name

Department of Periodontics, University of Damascus Dental School

City

Damascus

ZIP/Postal Code

DM20AM18

Country

Syrian Arab Republic

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

20528963

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.

Results Reference

background

PubMed Identifier

16460241

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.

Results Reference

background

PubMed Identifier

17760538

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.

Results Reference

background

PubMed Identifier

26888240

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.

Results Reference

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PubMed Identifier

19563287

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.

Results Reference

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PubMed Identifier

21443557

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.

Results Reference

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PubMed Identifier

23725027

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.

Results Reference

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PubMed Identifier

10505810

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.

Results Reference

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PubMed Identifier

16253095

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.

Results Reference

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PubMed Identifier

19335093

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.

Results Reference

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Semilunar and Conventional Coronally Positioned Flap for the Treatment Gingival Recession

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