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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04542486
• Other study ID #: PER 3-3-1
• Status: Completed
• Phase: N/A
• Start date: January 28, 2021
• Est. completion date: July 1, 2021

Study information

• Verified date: April 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: July 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Gingival Hyperplasia
• Hyperplasia
• Pain, Postoperative
• Wound Heal

Intervention

Procedure:
• Excision of gingival hyperplasia using "Soft tissue trimmer ".
Gingivoplasties and removal of excess gingival tissues using Soft tissue trimmer.
• Excision of gingival hyperplasia using the conventional scalpel technique
Excision of gingival hyperplasia in gingivoplasties using the conventional technique reverse bevel using 15c blade.

Locations

Country	Name	City	State
Egypt	Faculty of Oral and Dental Medicine-CU	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	Tissue colour	If it is either redder or whiter than the opposite side, or like opposite side tissue.	6 weeks.
Secondary	Bleeding	If bleeding spontaneously or on palpation exists or not.	From 3-5 days
Secondary	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.