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

Deep Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06205459
• Other study ID #: thermacut bur dentsply
• Status: Recruiting
• Phase: N/A
• Start date: February 2, 2024
• Est. completion date: April 1, 2025

Study information

• Verified date: January 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 1, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Deep Caries
• Dental Caries

Intervention

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.

Locations

Country	Name	City	State
Egypt	Faculty of dentistry Cairo university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	marginal integrity	using modified USPHS criteria	immediate post operative, 3 month, 6 month and 1 year
Primary	patient satisfaction: visual analogue scale	using visual analogue scale	immediate post operative, 3 month, 6 month and 1 year
Secondary	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