Deep Marginal Acquisition With Thermacut Bur Vs. Functional Crown Lengthening in Deep Carious Lesions
1 other identifier
interventional
30
1 country
1
Brief Summary
this clinical trial is conducted to compare between deep marginal acquistion by the means of thermacut bur Vs. functional crown lengthening in exposing deep subgingival interproximal cervical lesions
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 Feb 2024
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
April 26, 2020
CompletedFirst Posted
Study publicly available on registry
January 16, 2024
CompletedStudy Start
First participant enrolled
February 2, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2025
CompletedJanuary 16, 2024
January 1, 2024
1 year
April 26, 2020
January 11, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
patient satisfaction: visual analogue scale
using visual analogue scale
immediate post operative, 3 month, 6 month and 1 year
Secondary Outcomes (1)
Pocket depth and biological width
immediate post operative, 3 month, 6 month and 1 year
Other Outcomes (1)
marginal integrity
immediate post operative, 3 month, 6 month and 1 year
Study Arms (2)
intervention
EXPERIMENTALdeep marginal acquisition using thermacut bur from dentsply
control
ACTIVE COMPARATORfunctional crown lengthening
Interventions
thermacut bur is a tool which doesn't contain any abrasives so it is much safer on the root surface of both prepared and adjacent teeth, and yields better treatment outcome in cases when exposing deep margins is needed.
Eligibility Criteria
You may qualify if:
- \- Subject not less than 18 years of age
- Males or females
- Community-dwelling
- Have at least one deep subgingival interproximal carious lesion.
- Can comply to oral hygiene measures or with good oral hygiene
- Have sufficient cognitive ability to
- Understand consent procedures.
You may not qualify if:
- Patients less than 18 years old.
- Disabilities:
- Systemic diseases or severe medically compromised. (Cardiovascular disorder, diabetes, hypertensive, epileptic).
- Lack of compliance.
- Gingival hyperplasia, blood disorder.
- Cognitive impairment.
- Attachment loss signs of periodontal disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Faculty of dentistry Cairo university
Cairo, 11562, Egypt
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Master degree candidate, Conservative dentistry department, faculty of dentistry
Study Record Dates
First Submitted
April 26, 2020
First Posted
January 16, 2024
Study Start
February 2, 2024
Primary Completion
February 1, 2025
Study Completion
April 1, 2025
Last Updated
January 16, 2024
Record last verified: 2024-01