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

NCT ID: NCT04219436

Last Updated: 2025-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2019-11-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Group I (15 patients) (vertical mattress suturing technique) :

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

Group II (15 patients) (Figure of eight suturing technique) :

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Altered Passive Eruption of Teeth

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

2 arms undergoing the same surgical procedure but with different suturing techniques for flap closure
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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).

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

vertical mattress suturing technique

vertical mattress suturing technique is done to close the flap

Group Type ACTIVE_COMPARATOR

vertical mattress suturing technique

Intervention Type PROCEDURE

vertical mattress suturing technique used for flap closure after esthetic crown lengthening

figure of eight suturing technique

figure of eight suturing technique is done to close the flap

Group Type ACTIVE_COMPARATOR

figure of eight suturing technique

Intervention Type PROCEDURE

figure of eight suturing technique used for flap closure after esthetic crown lengthening

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

vertical mattress suturing technique

vertical mattress suturing technique used for flap closure after esthetic crown lengthening

Intervention Type PROCEDURE

figure of eight suturing technique

figure of eight suturing technique used for flap closure after esthetic crown lengthening

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ahmed Hesham Mohamed

teaching assisatnt

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

ahmed gamal, professor

Role: STUDY_DIRECTOR

faculty of dentistry ain shams university

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculty of Dentistry Ain Shams University

Cairo, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PER16-35M

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.