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Periodontal Dressing After Surgical Crown Lengthening

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ClinicalTrials.gov Identifier: NCT01986959
Recruitment Status : Completed
First Posted : November 19, 2013
Last Update Posted : November 19, 2013
Sponsor:
Information provided by (Responsible Party):
Raquel Pippi Antoniazzi, Franciscan University Center

Brief 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.


Condition or disease Intervention/treatment Phase
Pain Wound Healing Disturbance of Periodontal Infection Procedure: With Periodontal dressing Procedure: Without Periodontal dressing Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Periodontal Dressing After Surgical Crown Lengthening: A Randomized Clinical Trial
Study Start Date : September 2011
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

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

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01986959


Locations
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Brazil
School of Dentistry, Franciscan University Center
Santa Maria, RS, Brazil, 97010-491
Sponsors and Collaborators
Franciscan University Center

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Responsible Party: Raquel Pippi Antoniazzi, MS, Professor, School of Dentistry, Franciscan University Center (UNIFRA), Santa Maria, RS, Brazil;, Franciscan University Center
ClinicalTrials.gov Identifier: NCT01986959    
Other Study ID Numbers: Periodontal dressing 1246
First Posted: November 19, 2013    Key Record Dates
Last Update Posted: November 19, 2013
Last Verified: November 2013
Keywords provided by Raquel Pippi Antoniazzi, Franciscan University Center:
Periodontal Dressings
Surgical crown lengthening
Periodontal surgery