NCT01986959

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at below P25 for phase_2 pain

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 27, 2013

Completed
23 days until next milestone

First Posted

Study publicly available on registry

November 19, 2013

Completed
Last Updated

November 19, 2013

Status Verified

November 1, 2013

Enrollment Period

1.1 years

First QC Date

October 27, 2013

Last Update Submit

November 12, 2013

Conditions

PainWound Healing Disturbance ofPeriodontal Infection

Keywords

Periodontal DressingsSurgical crown lengtheningPeriodontal surgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Local infection

    seven Days

  • Healing

    Seven Days

  • Pain and discomfort

    Seven days

  • Gingival bleeding

    Seven days

Study Arms (2)

Surgery with Periodontal dressing

EXPERIMENTAL

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

Surgery without Periodontal dressing

OTHER

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

Interventions

With Periodontal dressingPROCEDURE

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.

Also known as: Coe-PakTM Regular (GC AMERICA INC, Alsip, IL, USA)
Surgery with Periodontal dressing
Without Periodontal dressingPROCEDURE

The dressing was not inserted.

Surgery without Periodontal dressing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Dentistry, Franciscan University Center

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

Location

MeSH Terms

Conditions

Pain

Interventions

Periodontal Dressings

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PeriodonticsDentistry

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MS, Professor, School of Dentistry, Franciscan University Center (UNIFRA), Santa Maria, RS, Brazil;

Study Record Dates

First Submitted

October 27, 2013

First Posted

November 19, 2013

Study Start

September 1, 2011

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

November 19, 2013

Record last verified: 2013-11

Locations

BR(1)