Periodontal Dressing After Surgical Crown Lengthening

Periodontal Dressing After Surgical Crown Lengthening: A Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Pain; Wound Healing Disturbance of; Periodontal Infection
• Intervention / Treatment: Procedure: With Periodontal dressing; Procedure: Without Periodontal dressing

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Phase 2

Contacts and Locations

Study Locations

• Brazil
  • RS
    • Santa Maria, RS, Brazil, 97010-491
      • School of Dentistry, Franciscan University Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Procedure: 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.; Other Names: Coe-PakTM Regular (GC AMERICA INC, Alsip, IL, USA)
Other: 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).	Procedure: Without Periodontal dressing; The dressing was not inserted.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Position of the gingival margin	Following removal of the dressing, the examiner determined the position of the gingival margin. This position was determined individually using the same procedure performed in the immediate postoperative period based on the previously recorded fixed reference points. The determination of gingival recession, position of the gingival margin and gingival swelling was performed categorically, using the gingival margin in the immediate postoperative period for comparison.	Seven days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local infection	Infection was defined as present if the patient has at the surgical site, postoperative pain around the site, which increased in intensity at any time between 1 and 3 days after the procedure, with or without the presence of halitosis.	seven Days
Healing	The healing of the surgical wound was evaluated based on the type of migration of the free edges of epithelium. Healing by first intention was determined by the migration of the epithelium toward the bed of the wound. Cases in which an area of conjunctive tissue and/or bone was uncovered by epithelium and re-epithelialization by the adjacent epithelium was occurring were classified as healing by second intention	Seven Days
Pain and discomfort	A questionnaire for the evaluation of pain and sensitivity on the first, second, third and seventh days postoperatively was given to each patient to fill out at home. All evaluations involved a record of the number of analgesics taken as well as a visual analog scale (VAS, ranging from 0 [absence of pain] to 100 [unbearable pain] mm) and a verbal scale (VS) with the following responses: no pain; mild pain; moderate pain; severe pain; and very severe pain. The patients were instructed to fill out the scales between 8 and 9 pm every day. Following removal of the dressing, in seven days, the examiner administered the pain scales (VAS and VS).	Seven days
Gingival bleeding	Following removal of the dressing, the examiner determined the presence of gingival bleeding as present or absent (Ainamo and Bay, 1975.	Seven days

Collaborators and Investigators

• Sponsor: Franciscan University Center

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: October 27, 2013
• First Submitted That Met QC Criteria: November 12, 2013
• First Posted (Estimate): November 19, 2013

Study Record Updates

• Last Update Posted (Estimate): November 19, 2013
• Last Update Submitted That Met QC Criteria: November 12, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Periodontal Dressings; Surgical crown lengthening; Periodontal surgery
• Other Study ID Numbers: Periodontal dressing 1246