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

Cairo University28 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Pain, Postoperative Wound Heal Gingival Hyperplasia

Interventions

Excision of gingival hyperplasia using "Soft tissue trimmer ".PROCEDURE

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

Excision of gingival hyperplasia using the conventional scalpel techniquePROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Faculty of Oral and Dental Medicine-CU

Cairo, Egypt

Outcomes

Primary Outcomes

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.

Time frame: 7 days

Secondary Outcomes

Epithelization

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.

Tissue colour

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

Time frame: 6 weeks.

Bleeding

If bleeding spontaneously or on palpation exists or not.

Time frame: From 3-5 days

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.

Time frame: During surgical procedure itself.

Data from ClinicalTrials.gov

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