Clinical Efficacy of Soft Tissue Trimmer in Cases of Gingival Hyperplasia.
1 other identifier
interventional
28
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 2, 2020
CompletedFirst Posted
Study publicly available on registry
September 9, 2020
CompletedStudy Start
First participant enrolled
January 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2021
CompletedApril 13, 2022
April 1, 2022
1 month
September 2, 2020
April 5, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Epithelization
14 days.
Tissue colour
6 weeks.
Bleeding
From 3-5 days
Surgical time
During surgical procedure itself.
Study Arms (2)
The conventional approach:
EXPERIMENTALGingivoplasties and removal of excess gingival tissues through the conventional scalpel technique using a reverse bevel.
The intervention approach:
ACTIVE COMPARATORGingivoplasties and elimination of excess gingival tissues through the use of "Soft tissue trimmer".
Interventions
Gingivoplasties and removal of excess gingival tissues using Soft tissue trimmer.
Excision of gingival hyperplasia in gingivoplasties using the conventional technique reverse bevel using 15c blade.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Faculty of Oral and Dental Medicine-CU
Cairo, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 2, 2020
First Posted
September 9, 2020
Study Start
January 28, 2021
Primary Completion
March 1, 2021
Study Completion
July 1, 2021
Last Updated
April 13, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will share