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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02013661
Other study ID # C-12-ASA-10
Secondary ID
Status Completed
Phase Phase 0
First received November 27, 2013
Last updated December 16, 2013
Start date June 2011
Est. completion date June 2012

Study information

Verified date December 2013
Source Universitat Internacional de Catalunya
Contact n/a
Is FDA regulated No
Health authority Spain: Comité Ético de Investigación Clínica
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date June 2012
Est. primary completion date June 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Intervention

Procedure:
Periodontal resective surgery
surgical periodontal debridement is performed after periodontal phase I

Locations

Country Name City State
Spain Universitat Internacional de Catalunya San Cugat del Valles Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Universitat Internacional de Catalunya

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary presence or absence of Suture loosening Seven days after the surgical procedure, the surgeon assessed suture loosening; recording loose or not Loose seven days after surgery No
Secondary presence and level of erythema and edema. 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 No