Poor Aesthetic of Existing Restoration of ToothNCT06500546
The Effect of Different Adhesion Strategies on the Clinical Success
A study testing Treatment of cervical lesions in people with Poor Aesthetic of Existing Restoration of Tooth and Dental Restoration Failure of Marginal Integrity, run by Istanbul University.
Trial summary
The study will involve 41 people who regularly seek treatment at clinics. Participants must be in generally good health and be older than eighteen. must have at least 20 teeth in an occlusion and maintain appropriate dental hygiene. Read more about this study
- Who is it for?
- Ages 14 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Poor Aesthetic of Existing Restoration of Tooth, Dental Restoration Failure of Marginal Integrity, Unacceptable Morphology of Tooth Restoration
- What is being tested?
- Treatment of cervical lesions
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 14 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Over the age of 18 years
- Good oral hygiene normal occlusal relationship with natural dentition
- At least 20 teeth are in occlusion The tooth with the lesion must be vital. non-mobile and non-carious
- Accepts Healthy Volunteers
Who cannot join
- under the age of 18
- Poor oral hygiene poor general health condition
- Bruxism or uncontrolled parafunction
- Patients with periodontal or gingival diseases
About this study
Official title: The Effect of Different Adhesion Strategies on the Clinical Success of Non-caries Cervical Restorations.
The study will involve 41 people who regularly seek treatment at clinics. Participants must be in generally good health and be older than eighteen. must have at least 20 teeth in an occlusion and maintain appropriate dental hygiene. They have to be treated for a minimum of four non-cancerous cervical lesions in their mouths.Four non-carious cervical lesions from patients will be separated into four groups, and adhesive material will be applied to the lesions in each group using different procedures. Evaluation will be performed based on World Dental Federation (FDI) criteria after initial, ½, 1, 2, 3, 4, and 5 years.
Read the detailed description
The study will involve 41 people who regularly seek treatment at clinics. Participants must be in generally good health and be older than eighteen. must have at least 20 teeth in an occlusion and maintain appropriate dental hygiene. They have to be treated for a minimum of four non-cancerous cervical lesions in their mouths.Four non-carious cervical lesions from patients will be separated into four groups, and adhesive material will be applied to the lesions in each group using different procedures. Evaluation will be performed based on World Dental Federation (FDI) criteria after initial, ½, 1, 2, 3, 4, and 5 years. In each evaluation period, esthetic (surface gloss, surface coloration, marginal discoloration, color match and translucency, esthetic anatomic form), functional (fracture and retention, marginal adaptation), and biologic criteria (postoperative sensitivity and vitality, caries recurrence) will be evaluated.
- Conditions
- Poor Aesthetic of Existing Restoration of Tooth, Dental Restoration Failure of Marginal Integrity, Unacceptable Morphology of Tooth Restoration, Secondary Caries
- Being tested
- Treatment of cervical lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment of cervical lesionsProcedure or surgery
Also called differnet adhesion procedures
Four non-carious cervical lesions from patients will be separated into four groups according to according to the adhesion trategies described below:
- adhesive material will be applied in total-etch mode,
- adhesive material will be applied in self-etch,
- universal adhesive material will be applied for 10 sec. in total-etch mode, which includes rubbing,
- universal adhesive material will be applied for 10 sec. in self-etch mode, which includes rubbing,
| Study group | Role | What they receive |
|---|---|---|
| Adhesion Strategies | Other | Four non-carious cervical lesions from patients will be separated into four groups according to differnet adhesion strategies Receives: Procedure: Treatment of cervical lesions |
| Different procedure | Other | All lesions to which adhesives are applied according to different adhesion strategies will be restored with the same type of composite material. Receives: Procedure: Treatment of cervical lesions |
What is being measured
The primary outcome is the main question the study is designed to answer.
retention rate of restorations
survival of restorations discoloration, color match, translucency, esthetic anatomic form), functional (fracture and retention, marginal adaptation), and biologic criteria (postoperative sensitivity). and vitality, caries recurrence)
Measured: Restorations will be evaluated 1 week, 6 months, 12 months and 24 months after finishing.
Secondary outcomes (1)
retention rate of restorations
survival of restorations discoloration, color match, translucency, esthetic anatomic form), functional (fracture and retention, marginal adaptation), and biologic criteria (postoperative sensitivity). and vitality, caries recurrence)
Measured: Restorations will be evaluated 36 months, 48 months and 60 months after finishing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study startSep 2024 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Poor Aesthetic of Existing Restoration of ToothStudies of the same condition, open and under way.
- More trials run by Istanbul 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
- Model description
- comparison of restoration success
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Demirci, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06500546
- Sponsor's protocol ID
- 2018/58
- Status last verified
- Jul 2024
- First submitted
- 28 Jun 2024
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Adhesion Strategies on the Clinical Success of Non-caries Cervical Restorations.
- ClinicalTrials.gov ID
- NCT06500546
- Acronym / sponsor ID
- 2018/58
- Conditions
- Poor Aesthetic of Existing Restoration of Tooth, Dental Restoration Failure of Marginal Integrity, Unacceptable Morphology of Tooth Restoration, Secondary Caries
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 15 Jul 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.
The study will involve 41 people who regularly seek treatment at clinics. Participants must be in generally good health and be older than eighteen. must have at least 20 teeth in an occlusion and maintain appropriate dental hygiene. They have to be treated for a minimum of four non-cancerous cervical lesions in their mouths.Four non-carious cervical lesions from patients will be separated into four groups, and adhesive material will be applied to the lesions in each group using different procedures. Evaluation will be performed based on World Dental Federation (FDI) criteria after initial, ½, 1, 2, 3, 4, and 5 years.
Detailed description
The study will involve 41 people who regularly seek treatment at clinics. Participants must be in generally good health and be older than eighteen. must have at least 20 teeth in an occlusion and maintain appropriate dental hygiene. They have to be treated for a minimum of four non-cancerous cervical lesions in their mouths.Four non-carious cervical lesions from patients will be separated into four groups, and adhesive material will be applied to the lesions in each group using different procedures. Evaluation will be performed based on World Dental Federation (FDI) criteria after initial, ½, 1, 2, 3, 4, and 5 years. In each evaluation period, esthetic (surface gloss, surface coloration, marginal discoloration, color match and translucency, esthetic anatomic form), functional (fracture and retention, marginal adaptation), and biologic criteria (postoperative sensitivity and vitality, caries recurrence) will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- comparison of restoration success
| Arm | Type | Receives |
|---|---|---|
| Adhesion Strategies | Other | Procedure: Treatment of cervical lesionsFour non-carious cervical lesions from patients will be separated into four groups according to differnet adhesion strategies |
| Different procedure | Other | Procedure: Treatment of cervical lesionsAll lesions to which adhesives are applied according to different adhesion strategies will be restored with the same type of composite material. |
Who may qualify
- Ages
- 14 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Over the age of 18 years
- Good oral hygiene normal occlusal relationship with natural dentition
- At least 20 teeth are in occlusion The tooth with the lesion must be vital. non-mobile and non-carious
- Accepts Healthy Volunteers
Key exclusion criteria (4 listed)
- under the age of 18
- Poor oral hygiene poor general health condition
- Bruxism or uncontrolled parafunction
- Patients with periodontal or gingival diseases
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 |
|---|---|---|
| Treatment of cervical lesionsAlso: differnet adhesion proceduresFour non-carious cervical lesions from patients will be separated into four groups according to according to the adhesion trategies described below: 1. adhesive material will be applied in total-etch mode, 2. adhesive material will be applied in self-etch, 3. universal adhesive material will be applied for 10 sec. in total-etch mode, which includes rubbing, 4. universal adhesive material will be applied for 10 sec. in self-etch mode, which includes rubbing, | Procedure or surgery | Adhesion Strategies, Different procedure |
Primary outcome
retention rate of restorations
Time frame: Restorations will be evaluated 1 week, 6 months, 12 months and 24 months after finishing.
survival of restorations discoloration, color match, translucency, esthetic anatomic form), functional (fracture and retention, marginal adaptation), and biologic criteria (postoperative sensitivity). and vitality, caries recurrence)
1 secondary outcome
retention rate of restorations
Time frame: Restorations will be evaluated 36 months, 48 months and 60 months after finishing.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Poor Aesthetic of Existing Restoration of Tooth
Recruiting
Clinical Performance of Full Coverage Hybrid Ceramic Crowns in the Aesthetic Zone: A Randomized Clinical Trial
Dental Restoration Failure of Marginal Integrity, Poor Aesthetic of Existing Restoration of Tooth
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment of cervical lesions in people with Poor Aesthetic of Existing Restoration of Tooth and Dental Restoration Failure of Marginal Integrity, run by Istanbul University.
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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
retention rate of restorations (time frame: Restorations will be evaluated 1 week, 6 months, 12 months and 24 months after finishing.). 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 15 Jul 2024.