Clinical Efficacy of Soft Tissue Trimmer in Cases of Gingival Hyperplasia.

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT04542486
Collaborator
(none)
28
1
2
5.1
5.5

Study Details

Study Description

Brief Summary

Postoperative pain and wound healing are compared after using conventional scalpel technique in comparison with the intervention which is using Soft tissue Trimmer for cases of gingival hyperplasia.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Excision of gingival hyperplasia using "Soft tissue trimmer ".
  • Procedure: Excision of gingival hyperplasia using the conventional scalpel technique
N/A

Detailed Description

In the control group:
  1. Following the local anaesthetic administration, A reverse bevel gingivectomy will be performed with a #15c scalpel.

  2. The borderline of gingiva will be determined via the use of a pointer dental tweezers, and excessive gingival tissue will then be removed with Gracey curettes

  3. No periodontal packs to be applied to ensure accurate evaluations of follow-up pain and wound healing

In the intervention group:
  1. Following the local anaesthetics administration for the Soft tissue trimmer(STT) gingivectomies, Soft tissue trimmer will be used with 400-rpm rotary systems and with no serum irrigation, per the manufacturer's recommendation.

  2. Gingivoplasties will be performed with the same Soft tissue trimmer to easily provide a knife-edge appearance.

  3. No periodontal packs will be applied to ensure accurate evaluations of follow-up pain and wound healing.

Study Design

Study Type:
Interventional
Actual Enrollment :
28 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Clinical Efficacy of Soft Tissue Trimmer on Postoperative Pain and Wound Healing When Compared to the Conventional Surgical Excision of Gingival Hyperplasia: A Randomized Clinical Trial
Actual Study Start Date :
Jan 28, 2021
Actual Primary Completion Date :
Mar 1, 2021
Actual Study Completion Date :
Jul 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: The conventional approach:

Gingivoplasties and removal of excess gingival tissues through the conventional scalpel technique using a reverse bevel.

Procedure: Excision of gingival hyperplasia using the conventional scalpel technique
Excision of gingival hyperplasia in gingivoplasties using the conventional technique reverse bevel using 15c blade.

Active Comparator: The intervention approach:

Gingivoplasties and elimination of excess gingival tissues through the use of "Soft tissue trimmer".

Procedure: Excision of gingival hyperplasia using "Soft tissue trimmer ".
Gingivoplasties and removal of excess gingival tissues using Soft tissue trimmer.

Outcome Measures

Primary Outcome Measures

  1. Pain VAS [7 days]

    Visual Analogue Scale for Pain (numbers from 0 to 10 ('no pain' to 'worst pain imaginable') measured 1,3,5 and 7 days postoperatively.

Secondary Outcome Measures

  1. Epithelization [14 days.]

    Re-epithelization after removal of excess tissue will be assessed either partial or complete.This will be tested by toluidine blue (TB)

  2. Tissue colour [6 weeks.]

    If it is either redder or whiter than the opposite side, or like opposite side tissue.

  3. Bleeding [From 3-5 days]

    If bleeding spontaneously or on palpation exists or not.

  4. Surgical time [During surgical procedure itself.]

    Time taken for both groups of surgery( control and intervention) will be measured from the administration of anaesthesia till removal of excess tissues.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Anterior region (minimum of four teeth at each surgical site)

  • Age range (18-45) years old

  • Plaque-induced inflammatory gingival enlargement

  • Altered passive eruption

  • No clinical attachment loss

  • Systemically healthy individuals

Exclusion Criteria:
  • Gingival enlargement due to any systemic predisposing factors

  • Pregnancy and/or lactation

  • Allergy

  • Conditions requiring antibiotic prophylaxis and anti-inflammatory medications.

  • Acute or untreated periodontitis

  • Systemic disease that could influence the outcome of the treatment (i.e. Diabetes)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Oral and Dental Medicine-CU Cairo Egypt

Sponsors and Collaborators

  • Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mai Mohamed Sameh, Principal Investigator, Cairo University
ClinicalTrials.gov Identifier:
NCT04542486
Other Study ID Numbers:
  • PER 3-3-1
First Posted:
Sep 9, 2020
Last Update Posted:
Apr 13, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 13, 2022