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

NCT ID: NCT06205459

Last Updated: 2024-01-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-02
• Study Completion Date: 2025-04-01

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

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.

Conditions

Deep Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

intervention

deep marginal acquisition using thermacut bur from dentsply

Group Type: EXPERIMENTAL

deep marginal acquisition using thermacut bur

Intervention Type: PROCEDURE

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.

control

functional crown lengthening

Group Type: ACTIVE_COMPARATOR

deep marginal acquisition using thermacut bur

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

thermacut bur from dentsply

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Khairy Elmorsy

Master degree candidate, Conservative dentistry department, faculty of dentistry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of dentistry Cairo university

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Facility Contacts

operative department

Role: primary

dentmail@dentistry.cu.edu.eg

+201002159535

Other Identifiers

thermacut bur dentsply

Identifier Type: -

Identifier Source: org_study_id