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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Pain, Postoperative, Wound Heal, Gingival Hyperplasia

Intervention / Treatment
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* Procedure: Excision of gingival hyperplasia using Soft tissue trimmer .
* Procedure: Excision of gingival hyperplasia using the conventional scalpel technique


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The conventional approach:<br>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<br>* Excision of gingival hyperplasia in gingivoplasties using the conventional technique reverse bevel using 15c blade.<br>|
| Active Comparator: The intervention approach:<br>Gingivoplasties and elimination of excess gingival tissues through the use of Soft tissue trimmer. | Procedure: Excision of gingival hyperplasia using Soft tissue trimmer .<br>* Gingivoplasties and removal of excess gingival tissues using Soft tissue trimmer.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epithelization | Re-epithelization after removal of excess tissue will be assessed either partial or complete.This will be tested by toluidine blue (TB) | 14 days. | 
| Tissue colour | If it is either redder or whiter than the opposite side, or like opposite side tissue. | 6 weeks. | 
| Bleeding | If bleeding spontaneously or on palpation exists or not. | 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. | During surgical procedure itself. |