Periodontal Dressing After Surgical Crown Lengthening

NCT ID: NCT01986959

Last Updated: 2013-11-19

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

PHASE2

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-10-31

Brief Summary

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Background: There is controversy regarding the postoperative effects of periodontal dressing on the periodontium, pain and discomfort. The aim of the present study was to compare postoperative pain following surgical crown lengthening with and without the use of periodontal dressing.

Material and Methods: A blind, randomized, clinical trial was carried out with 36 patients. Following surgical crown lengthening, the individuals were randomly allocated to the periodontal dressing group (PDG) and control group (CG - non-placement of periodontal dressing). Pain and discomfort were analyzed using a visual analog scale (VAS), verbal scale (VS) and the number of analgesics consumed in seven days postoperatively. Postoperative infection, stability of the gingival margin and type of healing were also evaluated.

Detailed Description

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Conditions

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Pain Wound Healing Disturbance of Periodontal Infection

Keywords

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Periodontal Dressings Surgical crown lengthening Periodontal surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Surgery with Periodontal dressing

After the Surgical crown lengthening, the patients were randomly allocated to the periodontal dressing group (PDG) and control group (CG - non-placement of periodontal dressing).

Group Type EXPERIMENTAL

With Periodontal dressing

Intervention Type PROCEDURE

After surgery,the dressing was mixed with a sterile spatula on a sterile glass plate following the manufacturer's instructions (2 cm of each paste measured with a sterile endodontic ruler). Coe-PakTM Regular was the dressing employed. Mixing and placement were performed only by the specialists in periodontics to ensure standardization. The dressing was inserted into the surgical wounds and molded to the necessary shape after setting sufficiently. The removal of the periodontal dressing was done after seven days.

Surgery without Periodontal dressing

After surgery, the patients were randomly allocated to the periodontal dressing group (PDG) and control group (CG - non-placement of periodontal dressing).

Group Type OTHER

Without Periodontal dressing

Intervention Type PROCEDURE

The dressing was not inserted.

Interventions

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With Periodontal dressing

After surgery,the dressing was mixed with a sterile spatula on a sterile glass plate following the manufacturer's instructions (2 cm of each paste measured with a sterile endodontic ruler). Coe-PakTM Regular was the dressing employed. Mixing and placement were performed only by the specialists in periodontics to ensure standardization. The dressing was inserted into the surgical wounds and molded to the necessary shape after setting sufficiently. The removal of the periodontal dressing was done after seven days.

Intervention Type PROCEDURE

Without Periodontal dressing

The dressing was not inserted.

Intervention Type PROCEDURE

Other Intervention Names

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Coe-PakTM Regular (GC AMERICA INC, Alsip, IL, USA)

Eligibility Criteria

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Inclusion Criteria

* need for surgical crown lengthening on only one tooth with need for proximal osteotomy;
* aged 18 years or older;
* absence of systemic disease;
* absence of periodontal disease at the site of surgical crown lengthening;
* no restrictions regarding the procedure;
* no need for antimicrobial prophylaxis.

Exclusion Criteria

* failure to return for the postoperative evaluations;
* failure to fill out the charts correctly;
* occurrence of pulp alteration in the operated tooth following the procedure;
* occurrence of partial or total loss of the periodontal dressing;
* allergic reaction to periodontal dressing.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Franciscan University Center

OTHER

Sponsor Role lead

Responsible Party

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Raquel Pippi Antoniazzi

MS, Professor, School of Dentistry, Franciscan University Center (UNIFRA), Santa Maria, RS, Brazil;

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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School of Dentistry, Franciscan University Center

Santa Maria, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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Periodontal dressing 1246

Identifier Type: -

Identifier Source: org_study_id