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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Wound Heal; Gingival Hyperplasia
• Intervention / Treatment: Procedure: Excision of gingival hyperplasia using the conventional scalpel technique; Procedure: Excision of gingival hyperplasia using "Soft tissue trimmer ".

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of Oral and Dental Medicine-CU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 41 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2021
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): July 1, 2021

Study Registration Dates

• First Submitted: September 2, 2020
• First Submitted That Met QC Criteria: September 2, 2020
• First Posted (Actual): September 9, 2020

Study Record Updates

• Last Update Posted (Actual): April 13, 2022
• Last Update Submitted That Met QC Criteria: April 5, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Gingival Overgrowth; Pain, Postoperative; Hyperplasia; Gingival Hyperplasia
• Other Study ID Numbers: PER 3-3-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No