Deep CariesNCT06205459
Deep Marginal Acquisition With Thermacut Bur Vs. Functional Crown Lengthening in Deep Carious Lesions
A study testing deep marginal acquisition using thermacut bur in people with Deep Caries, run by Cairo University at 1 site in Egypt.
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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Deep Caries
- What is being tested?
- deep marginal acquisition using thermacut bur
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Feb 2024to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- 5- Understand consent procedures.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of dentistry Cairo university
Cairo, 11562
operative department, +201002159535, dentmail@dentistry.cu.edu.eg
About this study
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
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
Read the 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
- Being tested
- deep marginal acquisition using thermacut bur
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deep marginal acquisition using thermacut burProcedure or surgery
Also called thermacut bur from dentsply
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.
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | deep marginal acquisition using thermacut bur from dentsply Receives: Procedure: deep marginal acquisition using thermacut bur |
| control | Active comparator | functional crown lengthening Receives: Procedure: deep marginal acquisition using thermacut bur |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient satisfaction: visual analogue scale
using visual analogue scale
Measured: immediate post operative, 3 month, 6 month and 1 year
Secondary outcomes (1)
Pocket depth and biological width
Graded Periodontal Probe and (digital radiograph) bitewing with paralleling technique
Measured: immediate post operative, 3 month, 6 month and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start2 Feb 2024 (estimated)
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep CariesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Khairy Elmorsy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06205459
- Sponsor's protocol ID
- thermacut bur dentsply
- Status last verified
- Jan 2024
- First submitted
- 26 Apr 2020
- Last updated
- 16 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06205459
- Acronym / sponsor ID
- thermacut bur dentsply
- Conditions
- Deep Caries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 2 Feb 2024 (estimated)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 16 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Procedure: deep marginal acquisition using thermacut burdeep marginal acquisition using thermacut bur from dentsply |
| control | Active comparator | Procedure: deep marginal acquisition using thermacut burfunctional crown lengthening |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| deep marginal acquisition using thermacut burAlso: thermacut bur from dentsplythermacut 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. | Procedure or surgery | control, intervention |
Primary outcome
patient satisfaction: visual analogue scale
Time frame: immediate post operative, 3 month, 6 month and 1 year
using visual analogue scale
1 secondary outcome
Pocket depth and biological width
Time frame: immediate post operative, 3 month, 6 month and 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing deep marginal acquisition using thermacut bur in people with Deep Caries, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient satisfaction: visual analogue scale (time frame: immediate post operative, 3 month, 6 month and 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2024.