Periodontal Dressing After Surgical Crown Lengthening

Pain Clinical Trial

Official title:

Periodontal Dressing After Surgical Crown Lengthening: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01986959
• Other study ID #: Periodontal dressing 1246
• Status: Completed
• Phase: Phase 2
• First received: October 27, 2013
• Last updated: November 12, 2013
• Start date: September 2011
• Est. completion date: October 2012

Study information

• Verified date: November 2013
• Source: Franciscan University Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pain
• Periodontal Infection
• Wound Healing Disturbance of

Intervention

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.
• Without Periodontal dressing
The dressing was not inserted.

Locations

Country	Name	City	State
Brazil	School of Dentistry, Franciscan University Center	Santa Maria	RS

Sponsors (1)

Lead Sponsor	Collaborator
Franciscan University Center

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No