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NCT Number: NCT03391947

Semilunar and Conventional Coronally Positioned Flap for the Treatment Gingival Recession

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

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Key information

Conditions

Gingival Recession Gingival Diseases Mouth Diseases Periodontal Atrophy Periodontal Diseases Root Coverage Stomatognathic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Periodontics, University of Damascus Dental School

Damascus, DM20AM18, Syria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

semilunar coronally positioned flap

Procedure

The description of this intervention has been already given before

coronally advanced flap

Procedure

The description of this intervention has been already given before

Primary outcomes

  1. Change in the amount of root coverage

    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

    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 outcomes

  1. Change in visible plaque index

    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

    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

  2. Change in sulcus bleeding index

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

    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

  3. Change in probing depth

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

    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.

  4. Change in the clinical attachment level

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

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

  5. Change in the gingival recession width

    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

    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

  6. Change in the width of keratinized tissue

    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

    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.

  7. Change in the thickness of the keratinized tissue

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

  8. Change in the position of the mucogingival junction

    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

    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

  9. Change in the wound healing index

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

    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

  10. Change in post-operative pain level

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

    Using a 10 cm-visual analog scale

  11. Patients' satisfaction with aesthetics

    Time frame: at three months post-surgery

    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.

  12. Change in root sensitivity

    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

    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.

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 5, 2018
Registry last updated
Jul 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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