Clinical Evaluation of Sutures in Periodontal Surgery

December 16, 2013 updated by: Almudena Tasende Pereiro, Universitat Internacional de Catalunya

Clinical Evaluation of Four Types of Suture in Periodontal Surgery

The aims of this study were to evaluate and compare tissue erythema, edema and knot loosening among four types of suture one week after periodontal surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Forty patients participated in this prospective, randomized, double-blind clinical trial. Vertical mattress sutures were used following resective periodontal surgery performed by one operator. Four suture materials were selected for evaluation: 5-0 silk; 5-0 polypropylene; 5-0 polyglycolic acid (PGA), and 4-0 polytetrafluoroethylene (PTFE). Seven days after the surgical procedure, the surgeon assessed suture loosening and removed the sutures. A blind researcher clinically evaluated erythema and edema.

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • San Cugat del Valles, Barcelona, Spain, 08195
        • Universitat Internacional de Catalunya

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients treated at the CUO (dental clinic at the Universitat Internacional de Catalunya) that are prescribed for periodontal resective surgery

Description

Inclusion Criteria:

  • Qualification for the study was based on the need for resective periodontal surgery (apically positioned flap and osseous recontouring) at four or more consecutive interproximal sites per quadrant

Exclusion Criteria:

  • systemic diseases, such as diabetes, chronic obstructive pulmonary disease, or an immunologic disease that would affect wound healing; allergies to prescribed medication; and/or current pregnancy or breast feeding were excluded from the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Suture in Periodontal resective surgery
Four types of suture including silk, polypropylene, PGA, and PTFE
Procedure: Periodontal resective surgery
surgical periodontal debridement is performed after periodontal phase I

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
presence or absence of Suture loosening
Time Frame: seven days after surgery
Seven days after the surgical procedure, the surgeon assessed suture loosening; recording loose or not Loose
seven days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
presence and level of erythema and edema.
Time Frame: seven days after surgery
Seven days after the surgical procedure a blind researcher clinically evaluated erythema and edema. Adding a score related to a gingival index
seven days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitat Internacional de Catalunya

Investigators

  • Principal Investigator: Jose Nart, DDS, PhD, Universitat Internacional de Catalunya

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

November 27, 2013

First Submitted That Met QC Criteria

December 16, 2013

First Posted (Estimate)

December 17, 2013

Study Record Updates

Last Update Posted (Estimate)

December 17, 2013

Last Update Submitted That Met QC Criteria

December 16, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • C-12-ASA-10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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