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Completed

NCT Number: NCT01986959

Periodontal Dressing After Surgical Crown Lengthening

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Periodontal Infection Signs and Symptoms Wound Healing Disturbance of

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

School of Dentistry, Franciscan University Center

Santa Maria, Rio Grande do Sul, 97010-491, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

With Periodontal dressing

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.

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

Without Periodontal dressing

Procedure

The dressing was not inserted.

Primary outcomes

  1. Position of the gingival margin

    Time frame: Seven days

    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.

Secondary outcomes

  1. Local infection

    Time frame: seven Days

    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.

  2. Healing

    Time frame: Seven Days

    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

  3. Pain and discomfort

    Time frame: Seven days

    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).

  4. Gingival bleeding

    Time frame: Seven days

    Following removal of the dressing, the examiner determined the presence of gingival bleeding as present or absent (Ainamo and Bay, 1975.

Sponsors and collaborators

Lead sponsor

Franciscan University Center

Other

Registry information

Official study title

Periodontal Dressing After Surgical Crown Lengthening: A Randomized Clinical Trial

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 19, 2013
Registry last updated
Nov 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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