Papilla Suture Design Affects Papillary Postsurgical Dimensions

NCT ID: NCT05351463

Last Updated: 2022-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2022-01-01

Brief Summary

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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

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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.

Conditions

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Periodontal Surgery Oral Surgery

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

RCT parallel study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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one arm study

in each case one site was assigned as control site and one site was assigned as test site.

Group Type OTHER

papila suture technique

Intervention Type PROCEDURE

simple interupted vs internal horoizontal matress suture

Interventions

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papila suture technique

simple interupted vs internal horoizontal matress suture

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Polak David

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hadassah Medical Organization, Jerusalem, Israel

Jerusalem, , Israel

Site Status

Countries

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Israel

Other Identifiers

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HMO-0079-15

Identifier Type: -

Identifier Source: org_study_id

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