Semilunar and Conventional Coronally Positioned Flap for the Treatment Gingival Recession

N/ACompletedNCT03391947

Damascus University10 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Gingival Recession Root Coverage

Interventions

semilunar coronally positioned flapPROCEDURE

The description of this intervention has been already given before

coronally advanced flapPROCEDURE

The description of this intervention has been already given before

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Periodontics, University of Damascus Dental School

Damascus, Syria

Outcomes

Primary Outcomes

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.

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 Outcomes

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

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

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

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

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.

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

Data from ClinicalTrials.gov

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