The Effect of Using Two Different Suturing Techniques on Free Gingival Marginal Stability

Sponsor
Ain Shams University (Other)
Overall Status
Completed
CT.gov ID
NCT04219436
Collaborator
(none)
30
1
2
29
1

Study Details

Study Description

Brief Summary

Gummy smile is one of the major esthetic problems nowadays; it is due to several causes that either dental or skeletal. Etiology of the gummy smile is altered passive eruption, vertical maxillary excess, different gingival enlargement conditions, deficient maxillary lip length and excessive maxillary lip mobility, dento alveolar extrusion, combination of all these factors.

Altered passive eruption is considered to be one of the most major causes, it is classified into two types according to the location of the mucogingival junction with respect to the bone crest and each type has two subtypes . Esthetic crown lengthening is the treatment of choice for subtype B in both types as bone removal is mandatory to create a space for the biological width.

Most of the studies stated that there is some degree of relapse of the gingival tissues after the procedures in the follow ups, that relapse was related to the biotype of the gingival tissues, the flap placement close or far from the bone can be correlated to the suturing technique used for closure of the tissues.

In the investigator's study comparing of two different suturing technique was done to evaluated their effect on gingival tissue relapse, 30 patients (26 females and 4 males) were divided between 2 groups each group consisted of 15 patients. In the first group periosteal suturing technique was done in the second figure of eight (modified interrupted) suturing technique was.

Evaluation of the tissue relapse was done through the assessment of the amount of the attached gingival tissues level of gingival margin and marginal tissue contour before and after the surgery.

The results of the study showed that tissue relapse was more in the periosteal suturing technique group that was related to the pressure on the tissues due to the fixation of the suture at the periostium, the papillary tissue also showed more inflammation in the follow up period prior to suture removal. The figure of eight group showed less relapse and tissue inflammation as it prevents flap edge overlap and is tension free therefore better blood supply to the tissue.

Patients were generally satisfied post-surgical with their smile, gingival tissue visibility and teeth dimensions inspite of the relapse but it was better than prior to surgery. Also they would recommend it to other patients complaining from the same problem.

Condition or Disease Intervention/Treatment Phase
  • Procedure: esthetic crown leghthening
N/A

Detailed Description

Thirty patients (26 females, 4 males), who were candidates for esthetic crown lengthening, participated in this prospective clinical trial.

Group 1 (15 patients) (Periosteal suture) :

Esthetic crown lengthening procedure: internal bevel, sulcular and interdental incisions, flap elevation, bone removal then External vertical mattress suture was done (periosteal suture).

Group 2 (15 patients) (Figure of eight suture) :

Esthetic crown lengthening procedure: internal bevel, sulcular and interdental incisions, flap elevation, bone removal then modified interrupted suture was done (Figure of eight suture).

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
2 arms undergoing the same surgical procedure but with different suturing techniques for flap closure2 arms undergoing the same surgical procedure but with different suturing techniques for flap closure
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
The study consisted of two groups the number of patient was determined by sample size calculation through G power analysis (15 patients). Patients were randomly selected using computer generated randomization (www.randomizer.org).
Primary Purpose:
Treatment
Official Title:
The Effect of Using Two Different Suturing Techniques on Free Gingival Marginal Stability After Esthetic Crown Lengthening for Treatment of Gummy Smile (Randomized Clinical Trial)
Actual Study Start Date :
Jun 1, 2017
Actual Primary Completion Date :
Jun 1, 2018
Actual Study Completion Date :
Nov 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: periosteal suturing technique

periosteal suture is done to close the flap

Procedure: esthetic crown leghthening
two different suturing technique used for flap closure after esthetic crown lengthening
Other Names:
  • periosteal suture
  • figure of eight suture
  • Active Comparator: figure of eight suturing technique

    figure of eight suture is done to close the flap

    Procedure: esthetic crown leghthening
    two different suturing technique used for flap closure after esthetic crown lengthening
    Other Names:
  • periosteal suture
  • figure of eight suture
  • Outcome Measures

    Primary Outcome Measures

    1. evaluation of the marginal soft tissue levels rebound [6 months]

      determination of soft tissue rebound :measuring the amount of attached gingival tissues before and after the surgical procedure by periodontal probe(UNC 15) with reference point in a previously manufactured surgical stent before surgery

    Secondary Outcome Measures

    1. patient aesthetic satisfaction [6 months]

      Patient satisfaction criteria (through surveying by a questionnaire) Prior to surgery · How would the patient rate the gun shown when smiling, size of the upper teeth, the length of upper teeth and the width of it (way too little, too little, about enough and too much way too much) After surgery · Is the patient satisfied with the gingival display during talking and smiling, teeth display during talking and smiling (not at all, slightly, somewhat, very and extremely). · How was the procedure experience (much worse, worse, same as I thought, better and much better

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 40 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Patients complaining from gummy smile (altered passive eruption)

    • Bone level is 2 mm or less from the cemento enamel junction

    • Teeth included were free from any periodontal destruction

    • Good compliance with the plaque control instructions following initial therapy.

    • Availability for follow up and maintenance program

    Exclusion Criteria:
    • Presence of systemic diseases which could influence the outcome of the therapy (American society of anesthesiologists I, ASA I).

    • Patient suffering from periodontitis stage 4 grade c.

    • Presence of smoking habit.

    • Presence of occlusion interference.

    • Pregnant females and lactating females. .

    • Vulnerable groups of patients (handicapped, mentally retarded, prisoners).

    • Restored teeth.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Dentistry Ain Shams University Cairo Egypt

    Sponsors and Collaborators

    • Ain Shams University

    Investigators

    • Study Director: ahmed gamal, professor, faculty of dentistry ain shams university

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed Hesham Mohamed, teaching assisatnt, Ain Shams University
    ClinicalTrials.gov Identifier:
    NCT04219436
    Other Study ID Numbers:
    • PER16-35M
    First Posted:
    Jan 7, 2020
    Last Update Posted:
    Jan 7, 2020
    Last Verified:
    Jan 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ahmed Hesham Mohamed, teaching assisatnt, Ain Shams University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 7, 2020