Clinical trial NCT06496776: The Effect of a Suturing Technique on the Gingival Tissues Around Dental Implants
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Edentulous Jaw
Missing Teeth
Gingival Diseases
Lead sponsor: Damascus University
Sponsor class: OTHER
Collaborators: name: Al-Wataniya University
First posted: 2024-07-11
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in the width of the keratinized gingiva
timeFrame: This variable will be measured at one day before surgery (T0), at one month (T1) and two months (T2) after the implant surgical insertion.
measure: Change in the thickness of the keratinized gingiva
timeFrame: This variable will be measured at one day before surgery (T0), at one month (T1) and two months (T2) after the implant surgical insertion.
Secondary outcomes:
Other outcomes:
Locations:
city: Hama
country: Syrian Arab Republic
facility: Department of Oral and Maxillofacial Surgery
Study officials:
affiliation: Department of Oral and Maxillofacial Surgery, College of Dentistry, Al-Wataniya Private University
name: Tarek Khaled Abou-Agwa, DDS MSc PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.