NCT04542486CompletedNot Applicable
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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cairo University
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Pain VAS
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- 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
- •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)
Outcomes
Primary Outcomes
Pain VAS
Time Frame: 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 Outcomes
- Bleeding(From 3-5 days)
- Epithelization(14 days.)
- Tissue colour(6 weeks.)
- Surgical time(During surgical procedure itself.)
Investigators
Mai Mohamed Sameh
Principal Investigator
Cairo University
Study Sites (1)
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