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

Cairo University (CU)

Status: Completed

Conditions: Gingival Hyperplasia; Pain, Postoperative; Wound Heal

Treatments: Procedure: Excision of gingival hyperplasia using the conventional scalpel technique; Procedure: Excision of gingival hyperplasia using "Soft tissue trimmer ".

Study type: Interventional

Funder types: Other

Identifiers

NCT04542486

PER 3-3-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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28 participants in 2 patient groups

The conventional approach:

Experimental group

Description:

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

Treatment:

Procedure: Excision of gingival hyperplasia using the conventional scalpel technique

The intervention approach:

Active Comparator group

Description:

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

Treatment:

Procedure: Excision of gingival hyperplasia using "Soft tissue trimmer ".