Papilla Suture Design Affects Papillary Postsurgical Dimensions

Not Applicable

Completed

• Conditions: Periodontal Surgery; Oral Surgery
• Interventions: Procedure: papila suture technique

• Registration Number: NCT05351463
• Lead Sponsor: Hadassah Medical Organization

Brief Summary

The current prospective, randomized, controlled clinical trial aimed at comparing the impact of papillae suture technique on interdental papilla dimensions after periodontal surgery using a novel 3D intraoral scanning technique.

Detailed Description

Scientific rationale for study: Choosing the appropriate suture design for periodontal surgery may affect post-surgery tissue dimension. This is a critical issue in periodontal surgery due to the grave impact papilla play on soft tissue esthetics.

Principal findings: using the novel 3D scanning of the gingiva tissue show that simple interrupted suture negatively affect post-surgery papillary height and recession adjacent to the suture compared with vertical internal mattress suture.

Practical implications: the study provide evidence that allows the clinician to better choose the suture design that will allow optimal healing of the papilla. Furthermore, the study presents a novel 3D scanning method to analyzed dimensional changes in the soft tissue.

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2022-01-01
• Study Completion: 2022-01-01
• Status Verified: 2022-04
• Study First Submitted: 2022-04-14
• Study First Submitted QC: 2022-04-27
• Last Update Submitted: 2022-04-27
• Study First Posted: 2022-04-28
• Last Update Posted: 2022-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 18 years or older
• Systemically healthy (based on health questionnaire prior to treatment)
• Willingness to participate in the study
• Clinical requirement for periodontal\ implant surgery

Exclusion Criteria

• Diagnosis of diabetes/heart disease, thrombocytopenia\ coagulation factors deficiency
• Chronic use\abuse of drugs\ alcohol
• Pregnancy Smoking more than 10 cigarettes per day Antibiotic consumption in the last 3 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
one arm study	papila suture technique	in each case one site was assigned as control site and one site was assigned as test site.

Primary Outcome Measures

Name	Time	Method
papilary volume	12 weeks post surgery	changes in papilary volume using 3D scanner

Trial Locations

Locations (1)

Hadassah Medical Organization, Jerusalem, Israel; 🇮🇱 Jerusalem, Israel