AzTrials
AzTrials

Gingival RecessionNCT03391947

Semilunar and Conventional Coronally Positioned Flap for the Treatment Gingival Recession

A study testing semilunar coronally positioned flap and coronally advanced flap in people with Gingival Recession and Root Coverage, run by Damascus University at 1 site in Syria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Gingival Recession, Root Coverage
What is being tested?
semilunar coronally positioned flap and coronally advanced flap
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteSyria
Study dates
1 Dec 2017to 20 Dec 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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).

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Syria1 site

  • Department of Periodontics, University of Damascus Dental School

    Damascus, DM20AM18

Other trials in Syria

About this study

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

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

Read the 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.

Being tested
semilunar coronally positioned flap, coronally advanced flap
Keywords
gingival recession, semilunar coronally flap, coronally advanced flap
Medical subject headings
Gingival Recession

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • semilunar coronally positioned flapProcedure or surgery

    The description of this intervention has been already given before

  • coronally advanced flapProcedure or surgery

    The description of this intervention has been already given before

Study groups in NCT03391947
Study groupRoleWhat they receive
semilunar coronally positioned flapExperimentalA 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.
Receives: Procedure: semilunar coronally positioned flap
coronally advanced flapActive comparatorCoronally 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.
Receives: Procedure: coronally advanced flap

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: (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 (12)

  1. 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

    Measured: (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

  2. 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

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

  3. 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.

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

  4. 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).

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

  5. 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

    Measured: (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

  6. 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.

    Measured: (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

  7. Change in the thickness of the keratinized tissue

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

  8. 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

    Measured: (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

  9. 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

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

  10. Change in post-operative pain level

    Using a 10 cm-visual analog scale

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

  11. 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.

    Measured: at three months post-surgery

  12. 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.

    Measured: (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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2018
  2. Study start1 Dec 2017
  3. Primary completion1 Aug 2018
  4. Study completion20 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
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
Single blind
Who is masked
Participant
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03391947
Sponsor's protocol ID
UDDS-Perio-01-2018
Status last verified
Jul 2019
First submitted
31 Dec 2017
Last updated
18 Jul 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 20528963

  • 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.

    PubMed 16460241

  • 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.

    PubMed 17760538

  • 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.

    PubMed 26888240

  • 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.

    PubMed 19563287

  • 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.

    PubMed 21443557

  • 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.

    PubMed 23725027

  • 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.

    PubMed 10505810

  • 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.

    PubMed 16253095

  • 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.

    PubMed 19335093

Questions about this trial

What is this clinical trial studying?

A study testing semilunar coronally positioned flap and coronally advanced flap in people with Gingival Recession and Root Coverage, run by Damascus University at 1 site in Syria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03391947, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in