Deep Marginal Acquisition With Thermacut Bur Vs. Functional Crown Lengthening in Deep Carious Lesions

Deep Marginal Acquisition With Thermacut Bur Versus Functional Crown Lengthening in Management of Deep Subgingival Interproximal Carious Lesions: A One Year Follow-up Randomized Controlled Trial

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

Study Overview

• Status: Recruiting
• Conditions: Deep Caries
• Intervention / Treatment: Procedure: deep marginal acquisition using thermacut bur

Detailed Description

Deep subgingival margins pose a great difficulty during restorative work with composite restorations. Exposing cavity margins is paramount in order to attain proper isolation, matrix adaptation and composite placement.

Several methods have been proposed to overcome the problem of exposing deep margins; functional crown lengthening is considered the gold standard of care regarding exposure of deep margins.

However, functional crown lengthening can pose many problems including the risk of root exposure, furcation involvement and compromising crown root ratio, besides risk of thread exposure if it is done beside implant, removal of bone from adjacent teeth and from buccal and lingual walls in order to create smooth bone architecture, and the complications of surgery such as post-operative pain, inflammation and edema and the risk of excessive bleeding.

Deep marginal acquisition and deep marginal extension (DMA & DME) are considered as a viable option in treating deep subgingival extended margins.

Several methods regarding deep marginal acquisition have been proposed including the use of diode laser and Electrosurgery, there is another protocol for exposing the gingival seat by the use of thermacut bur.

The rationale behind conducting this research is to propose an easy and predictable way to expose deep subgingival margins, without the need to perform surgical intervention.

The technique is done by clinicians with good outcomes, but never been tested or validated, this study is performed to verify whether this test should be validated or not.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11562
    • Recruiting
    • Faculty of Dentistry Cairo University
    • Contact: operative department; Phone Number: +201002159535; Email: dentmail@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

- Subject not less than 18 years of age

1. Males or females
2. Community-dwelling
3. Have at least one deep subgingival interproximal carious lesion.
4. Can comply to oral hygiene measures or with good oral hygiene
5. Have sufficient cognitive ability to

5- Understand consent procedures.

Exclusion Criteria:

1. Patients less than 18 years old.
2. Disabilities:
3. Systemic diseases or severe medically compromised. (Cardiovascular disorder, diabetes, hypertensive, epileptic).
4. Lack of compliance.
5. Gingival hyperplasia, blood disorder.
6. Cognitive impairment.
7. Attachment loss signs of periodontal disease.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention; deep marginal acquisition using thermacut bur from dentsply	Procedure: deep marginal acquisition using thermacut bur; 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.; Other Names: thermacut bur from dentsply
Active Comparator: control; functional crown lengthening	Procedure: deep marginal acquisition using thermacut bur; 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.; Other Names: thermacut bur from dentsply

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient satisfaction: visual analogue scale	using visual analogue scale	immediate post operative, 3 month, 6 month and 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pocket depth and biological width	Graded Periodontal Probe and (digital radiograph) bitewing with paralleling technique	immediate post operative, 3 month, 6 month and 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
marginal integrity	using modified USPHS criteria	immediate post operative, 3 month, 6 month and 1 year

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): February 2, 2024
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: April 26, 2020
• First Submitted That Met QC Criteria: January 11, 2024
• First Posted (Estimated): January 15, 2024

Study Record Updates

• Last Update Posted (Estimated): January 15, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: thermacut bur dentsply

Drug and device information, study documents

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