Papilla Suture Design Affects Papillary Postsurgical Dimensions

Oral Surgery Clinical Trial

Official title:

Papilla Suture Design Affects Papillary Postsurgical Dimensions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05351463
• Other study ID #: HMO-0079-15
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: January 1, 2022

Study information

• Verified date: April 2022
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Oral Surgery

Intervention

Procedure:
• papila suture technique
simple interupted vs internal horoizontal matress suture

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization, Jerusalem, Israel	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	papilary volume	changes in papilary volume using 3D scanner	12 weeks post surgery