The Effect of a Suturing Technique on the Gingival Tissues Around Dental Implants

July 4, 2024 updated by: Damascus University

The Effect of a Horizontal Apical Mattress Suturing Technique on the Width and Thickness of the Keratinized Mucosa After Dental Implant Surgery: A Clinical Trial

There is general agreement that a thick zone of the keratinized tissues around implants promotes accurate prosthetic procedures, permits oral hygiene maintenance, resists recession, and enables esthetic blending with surrounding tissues. A new procedure called Choukroun's technique has been suggested, and it consists of a combination of horizontal apical mattress suture with regular suture to increase the keratinized tissue in the mandibular arch during the first stage after implantation. The proposed procedure has not been evaluated yet in a cohort of patients. Therefore, this study aimed to evaluate the impact of Choukroun's technique on the width and thickness of the keratinized gingiva after oral surgery.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

A clinical trial will be conducted on patients referred to the Department of Oral and Maxillofacial Surgery at the Faculty of Dentistry, Al-Wataniya Private University, who have been referred to undergo dental implant surgery. The inclusion criteria for the study group were as follows: patients with mandibular missing teeth, good oral health, good general health, 18 to 70 years old, at least 1 mm thickness of keratinized gingiva, and at least 1 mm width of the attached gingiva. A total of 14 patients aged 27 to 67 years will be included in the study. After inserting the dental implants, the suturing will be conducted according to Choukroun's method.

The width and thickness of the keratinized gingiva will be assessed before surgery and at one and two months post-surgery. Repeated measures Analysis of Variance (ANOVA) will be applied to detect significant differences between assessment times.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Hama, Syrian Arab Republic, 332H 67A
        • Department of Oral and Maxillofacial Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with mandibular missing teeth
  • Good oral health
  • Good general health
  • Male or female
  • Age between 18 and 70 years old,
  • Thickness of the keratinized gingiva is at least 1 mm,
  • The width of the attached gingiva is at least 1 mm.

Exclusion Criteria:

  • Patients who are smokers
  • Pregnant or lactating women
  • Patients with systemic diseases
  • Patients who have been taking medication in the last six months that could influence wound healing after surgery and
  • Patients with oral inflammation such as periodontal disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Choukroun's method
Patients in this group will have a specific suturing technique (called Choukroun's method) after dental implant insertion.
Suturing will be done using the method described by Choukroun.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the width of the keratinized gingiva
Time Frame: This variable will be measured at one day before surgery (T0), at one month (T1) and two months (T2) after the implant surgical insertion.
The width of the attached gingiva will be measured using a periodontal probe (William's probe). This measurement will be made at the mesial, distal, and middle positions within the surgical area (from the crest of the alveolar ridge to the mucogingival junction), and the mean of these measurements will be recorded.
This variable will be measured at one day before surgery (T0), at one month (T1) and two months (T2) after the implant surgical insertion.
Change in the thickness of the keratinized gingiva
Time Frame: This variable will be measured at one day before surgery (T0), at one month (T1) and two months (T2) after the implant surgical insertion.
To measure the thickness of the keratinized gingiva, an endodontic file equipped with a rubber tip will be used to penetrate the gingiva at various points within the surgical area until it reaches the bone surface. These points are located midway between the mid-crestal of keratinized gingiva and the mucogingival junction, spaced 2 millimeters apart, and extending from the mesial to the distal aspects of the surgical area. The thickness will be then measured using a ruler, and the mean of these values will be recorded.
This variable will be measured at one day before surgery (T0), at one month (T1) and two months (T2) after the implant surgical insertion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Tarek Khaled Abou-Agwa, DDS MSc PhD, Department of Oral and Maxillofacial Surgery, College of Dentistry, Al-Wataniya Private University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2022

Primary Completion (Actual)

February 13, 2023

Study Completion (Actual)

April 15, 2023

Study Registration Dates

First Submitted

July 4, 2024

First Submitted That Met QC Criteria

July 4, 2024

First Posted (Actual)

July 11, 2024

Study Record Updates

Last Update Posted (Actual)

July 11, 2024

Last Update Submitted That Met QC Criteria

July 4, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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