Papilla Suture Design Affects Papillary Postsurgical Dimensions

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.

Study Overview

• Status: Completed
• Conditions: Oral Surgery; Periodontal Surgery
• Intervention / Treatment: Procedure: papila suture 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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel
    • Hadassah Medical Organization, Jerusalem, Israel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: one arm study; in each case one site was assigned as control site and one site was assigned as test site.	Procedure: papila suture technique; simple interupted vs internal horoizontal matress suture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
papilary volume	changes in papilary volume using 3D scanner	12 weeks post surgery

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): January 1, 2022
• Study Completion (Actual): January 1, 2022

Study Registration Dates

• First Submitted: April 14, 2022
• First Submitted That Met QC Criteria: April 27, 2022
• First Posted (Actual): April 28, 2022

Study Record Updates

• Last Update Posted (Actual): April 28, 2022
• Last Update Submitted That Met QC Criteria: April 27, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: HMO-0079-15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No