- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06496776
The Effect of a Suturing Technique on the Gingival Tissues Around Dental Implants
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
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Hama, Syrian Arab Republic, 332H 67A
- Department of Oral and Maxillofacial Surgery
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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 |
|---|---|
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Experimental: Choukroun's method
Patients in this group will have a specific suturing technique (called Choukroun's method) after dental implant insertion.
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Suturing will be done using the method described by Choukroun.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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.
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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.
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This variable will be measured at one day before surgery (T0), at one month (T1) and two months (T2) after the implant surgical insertion.
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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.
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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.
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This variable will be measured at one day before surgery (T0), at one month (T1) and two months (T2) after the implant surgical insertion.
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Collaborators and Investigators
Sponsor
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
General Publications
- Silverstein LH, Kurtzman GM, Shatz PC. Suturing for optimal soft-tissue management. J Oral Implantol. 2009;35(2):82-90. doi: 10.1563/1548-1336-35.2.82.
- Banche G, Roana J, Mandras N, Amasio M, Gallesio C, Allizond V, Angeretti A, Tullio V, Cuffini AM. Microbial adherence on various intraoral suture materials in patients undergoing dental surgery. J Oral Maxillofac Surg. 2007 Aug;65(8):1503-7. doi: 10.1016/j.joms.2006.10.066.
- Rodeheaver GT, Beltran KA, Green CW, Faulkner BC, Stiles BM, Stanimir GW, Traeland H, Fried GM, Brown HC, Edlich RF. Biomechanical and clinical performance of a new synthetic monofilament absorbable suture. J Long Term Eff Med Implants. 1996;6(3-4):181-98.
- Lee WH, Kuchler U, Cha JK, Stavropoulos A, Lee JS. Distance of insertion points in a mattress suture from the wound margin for ideal primary closure in alveolar mucosa: an in vitro experimental study. J Periodontal Implant Sci. 2021 Jun;51(3):189-198. doi: 10.5051/jpis.2100680034.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UDDS-OMFS-2-2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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