NCT06496776

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 4, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 11, 2024

Completed
Last Updated

July 11, 2024

Status Verified

July 1, 2024

Enrollment Period

5 months

First QC Date

July 4, 2024

Last Update Submit

July 4, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in the width of the keratinized gingiva

    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

    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.

Study Arms (1)

Choukroun's method

EXPERIMENTAL

Patients in this group will have a specific suturing technique (called Choukroun's method) after dental implant insertion.

Procedure: Choukroun's technique

Interventions

Suturing will be done using the method described by Choukroun.

Choukroun's method

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Oral and Maxillofacial Surgery

Hama, 332H 67A, Syria

Location

Related Publications (4)

  • 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.

    PMID: 19400063BACKGROUND
  • 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.

    PMID: 17656275BACKGROUND
  • 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.

    PMID: 10167360BACKGROUND
  • 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.

    PMID: 34114382BACKGROUND

MeSH Terms

Conditions

Jaw, EdentulousAnodontiaGingival Diseases

Condition Hierarchy (Ancestors)

Jaw DiseasesMusculoskeletal DiseasesStomatognathic DiseasesMouth, EdentulousMouth DiseasesTooth DiseasesTooth AbnormalitiesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPeriodontal Diseases

Study Officials

  • Tarek Khaled Abou-Agwa, DDS MSc PhD

    Department of Oral and Maxillofacial Surgery, College of Dentistry, Al-Wataniya Private University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2024

First Posted

July 11, 2024

Study Start

September 15, 2022

Primary Completion

February 13, 2023

Study Completion

April 15, 2023

Last Updated

July 11, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations