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

NCT ID: NCT04542486

Last Updated: 2022-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-28
• Study Completion Date: 2021-07-01

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:

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.

Conditions

Pain, Postoperative; Wound Heal; Gingival Hyperplasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

The conventional approach:

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

Group Type: EXPERIMENTAL

Excision of gingival hyperplasia using the conventional scalpel technique

Intervention Type: PROCEDURE

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

The intervention approach:

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

Group Type: ACTIVE_COMPARATOR

Excision of gingival hyperplasia using "Soft tissue trimmer ".

Intervention Type: PROCEDURE

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

Interventions

Excision of gingival hyperplasia using "Soft tissue trimmer ".

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

Intervention Type: PROCEDURE

Excision of gingival hyperplasia using the conventional scalpel technique

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

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mai Mohamed Sameh

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Oral and Dental Medicine-CU

Cairo, , Egypt

Countries

Egypt

Other Identifiers

PER 3-3-1

Identifier Type: -

Identifier Source: org_study_id