Edentulous JawNCT06496776
The Effect of a Suturing Technique on the Gingival Tissues Around Dental Implants
A study testing Choukroun's technique in people with Edentulous Jaw and Missing Teeth, run by Damascus University at 1 site in Syria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Edentulous Jaw, Missing Teeth, Gingival Diseases
- What is being tested?
- Choukroun's technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteSyria
- Study dates
- 15 Sep 2022to 15 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Edentulous Jaw, Missing Teeth, Gingival Diseases
- Being tested
- Choukroun's technique
- Medical subject headings
- Jaw, Edentulous, Anodontia, Gingival Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Choukroun's techniqueProcedure or surgery
Suturing will be done using the method described by Choukroun.
| Study group | Role | What they receive |
|---|---|---|
| Choukroun's method | Experimental | Patients in this group will have a specific suturing technique (called Choukroun's method) after dental implant insertion. Receives: Procedure: Choukroun's technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: This variable will be measured at one day before surgery (T0), at one month (T1) and two months (T2) after the implant surgical insertion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start15 Sep 2022
- Primary completion13 Feb 2023
- Study completion15 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Edentulous JawStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Collaborators
- Al-Wataniya University
- Responsible party
- Sponsor
- Investigators
- Tarek Khaled Abou-Agwa, DDS MSc PhD, Principal investigator, Department of Oral and Maxillofacial Surgery, College of Dentistry, Al-Wataniya Private University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06496776
- Sponsor's protocol ID
- UDDS-OMFS-2-2024
- Status last verified
- Jul 2024
- First submitted
- 4 Jul 2024
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 19400063Banche 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.
PubMed 17656275Rodeheaver 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.
PubMed 10167360Lee 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.
PubMed 34114382
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06496776
- Acronym / sponsor ID
- UDDS-OMFS-2-2024
- Conditions
- Edentulous Jaw, Missing Teeth, Gingival Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Collaborators
- Al-Wataniya University
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 13 Feb 2023 (actual)
- Study completion
- 15 Apr 2023 (actual)
- First posted
- 11 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Choukroun's method | Experimental | Procedure: Choukroun's techniquePatients in this group will have a specific suturing technique (called Choukroun's method) after dental implant insertion. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with mandibular missing teeth
- Good oral health
- Good general health
- Male or female
- Age between 18 and 70 years old,
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Choukroun's techniqueSuturing will be done using the method described by Choukroun. | Procedure or surgery | Choukroun's method |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Background: PubMed 19400063Silverstein 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.
- Background: PubMed 17656275Banche 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.
- Background: PubMed 10167360Rodeheaver 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.
- Background: PubMed 34114382Lee 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tarek Khaled Abou-Agwa, DDS MSc PhD principal investigator
Department of Oral and Maxillofacial Surgery, College of Dentistry, Al-Wataniya Private University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Choukroun's technique in people with Edentulous Jaw and Missing Teeth, run by Damascus University at 1 site in Syria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06496776, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2024; AzTrials last refreshed its copy on 6 Nov 2026.