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

Primary Purpose

Pain, Postoperative, Wound Heal, Gingival Hyperplasia

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Excision of gingival hyperplasia using "Soft tissue trimmer ".

Excision of gingival hyperplasia using the conventional scalpel technique

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

Faculty of Oral and Dental Medicine-CU

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

The conventional approach:

The intervention approach:

Arm Description

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

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

Outcomes

Primary Outcome Measures

Pain VAS

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

Epithelization

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

Tissue colour

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

Bleeding

If bleeding spontaneously or on palpation exists or not.

Surgical time

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

Full Information

NCT ID

NCT04542486

First Posted

September 2, 2020

Last Updated

April 5, 2022

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT04542486

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

January 28, 2021 (Actual)

Primary Completion Date

March 1, 2021 (Actual)

Study Completion Date

July 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

Detailed Description

In the control group: Following the local anaesthetic administration, A reverse bevel gingivectomy will be performed with a #15c scalpel. 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 No periodontal packs to be applied to ensure accurate evaluations of follow-up pain and wound healing In the intervention group: 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. Gingivoplasties will be performed with the same Soft tissue trimmer to easily provide a knife-edge appearance. No periodontal packs will be applied to ensure accurate evaluations of follow-up pain and wound healing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Postoperative, Wound Heal, Gingival Hyperplasia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

The conventional approach:

Arm Type

Experimental

Arm Description

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

Arm Title

The intervention approach:

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Excision of gingival hyperplasia using "Soft tissue trimmer ".

Intervention Description

Gingivoplasties and removal of excess gingival tissues using Soft tissue trimmer.

Intervention Type

Procedure

Intervention Name(s)

Excision of gingival hyperplasia using the conventional scalpel technique

Intervention Description

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

Primary Outcome Measure Information:

Title

Pain VAS

Description

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

Time Frame

7 days

Secondary Outcome Measure Information:

Title

Epithelization

Description

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

Time Frame

14 days.

Title

Tissue colour

Description

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

Time Frame

6 weeks.

Title

Bleeding

Description

If bleeding spontaneously or on palpation exists or not.

Time Frame

From 3-5 days

Title

Surgical time

Description

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

Time Frame

During surgical procedure itself.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Facility Information:

Facility Name

Faculty of Oral and Dental Medicine-CU

City

Cairo

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

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

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