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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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06205459
Enrollment
30
Registered
2024-01-16
Start date
2024-02-02
Completion date
2025-04-01
Last updated
2024-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep Caries

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.

Interventions

PROCEDUREdeep 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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
patient satisfaction: visual analogue scaleimmediate post operative, 3 month, 6 month and 1 yearusing visual analogue scale

Secondary

MeasureTime frameDescription
Pocket depth and biological widthimmediate post operative, 3 month, 6 month and 1 yearGraded Periodontal Probe and (digital radiograph) bitewing with paralleling technique

Other

MeasureTime frameDescription
marginal integrityimmediate post operative, 3 month, 6 month and 1 yearusing modified USPHS criteria

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026