Papilla Suture Design Affects Papillary Postsurgical Dimensions

Sponsor

Hadassah Medical Organization (Other)

Overall Status

Completed

CT.gov ID

NCT05351463

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Periodontal Surgery Oral Surgery	Procedure: papila suture technique	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

RCT parallel studyRCT parallel study

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Papilla Suture Design Affects Papillary Postsurgical Dimensions

Actual Study Start Date :

Jan 1, 2020

Actual Primary Completion Date :

Jan 1, 2022

Actual Study Completion Date :

Jan 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

papilary volume [12 weeks post surgery]
changes in papilary volume using 3D scanner

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hadassah Medical Organization, Jerusalem, Israel	Jerusalem		Israel

Sponsors and Collaborators

Hadassah Medical Organization

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Polak David, Principal Investigator, Hadassah Medical Organization

ClinicalTrials.gov Identifier:

NCT05351463

Other Study ID Numbers:

HMO-0079-15

First Posted:

Apr 28, 2022

Last Update Posted:

Apr 28, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Apr 28, 2022