RetentionNCT06393699
Restoration of Non-carious Cervical Lesions With Different Resin Composites and Universal Adhesive
A study testing composite restoration in people with Retention, run by Ain Shams University at 1 site in Egypt.
Trial summary
patients with non carious cervical lesions suffer from dentin sensitivity and presence of cavitations and gingival recession. Restoring these lesions with different composites and evaluation of restorations every 6 months will be done to know the effect of different composite types and consistencies in retention of… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Retention
- What is being tested?
- composite restoration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 14 May 2022to 30 Dec 2026
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients' age will range from 18 to 65 years.
- Presence of at least 2 NCCLs in one side.
- Patients with no medical condition could interfere with the routine dental care.
- Patients who will be able to attend for each recall visit.
- Patients with healthy periodontal tissues.
- Cavities presenting no more than 50% of margins in enamel.
Who cannot join
- Medically compromised patients.
- Pregnant or breast-feeding patients.
- Patients undergoing orthodontic treatment or bleaching treatment in the time of the study.
- Patients with periodontal disease in the target area.
- Patients presented with less than 20 teeth in the oral cavity.
- Patients without antagonists.
- Lesions superimposed with caries
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Restoration of Non-carious Cervical Lesions: The Effect of Different Resin Composites Bonded With A Universal Adhesive Utilizing Two Adhesion Approaches: A Randomized Clinical Study
patients with non carious cervical lesions suffer from dentin sensitivity and presence of cavitations and gingival recession. Restoring these lesions with different composites and evaluation of restorations every 6 months will be done to know the effect of different composite types and consistencies in retention of restorations of such lesions.
Read the detailed description
A split-mouth randomized clinical trial (RCT), based on the adhesion strategy, will be held on 52 patients attending to the outpatient clinics of the department of operative dentistry, Faculty of Dentistry, Ain Shams University with 2 non-carious cervical lesions in each side. Patients included in this study are those who seek restorative treatment of non-carious cervical lesions (NCCLs) in premolars and canines, which are due to chemical and/or mechanical predisposing factors. An informed consent will be signed by all participants who will be allocated in this study before being involved in the study. Male and female patients will be selected according to the inclusion and exclusion criteria. The patients will be randomly assigned into 4 main groups (n=13 patients/group) according to the type of restorative material will be inserted. In each group, two adhesive approaches will be employed, either etch-and-rinse (E\&R) or self-etching (SE)approach. For each patient's mouth, one side will receive restorations with the etch-and-rinse approach (n=26 restorations/E\&R approach), while the other side will receive restorations using the self-etching approach (n=26 restorations/SE approach). This will result in a total of 208 restorations will be inserted in this study. A treatment follow-up will be performed every six months for two years to investigate the clinical performance of the different resin composite restorations/the two different adhesive approaches.
Restorations will be evaluated at baseline and every 6 months by two blinded examiners, who will not be involved in the study. During evaluation, the examiners will not be informed about the type of restoration used or the adhesive approach and will have a code for each patient and the restored tooth. Restorations will be evaluated according to the modified United State Public Health Service criteria (USPHS).(6,9,13,30) Primary outcome will be the retention of the restoration, but the following secondary outcomes as marginal discoloration and adaptation, anatomic form, secondary caries, texture, and postoperative sensitivity will be also evaluated.
- Conditions
- Retention
- Being tested
- composite restoration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
composite restorationProcedure or surgery
different types of resin composite restorations will be used to restore NCCL
| Study group | Role | What they receive |
|---|---|---|
| incremental | Experimental | application of increments of packable composite in non carious cervical lesions Receives: Procedure: composite restoration |
| bulk fill heated | Experimental | application of heated composite as bulk in the lesions without incrementation after heating with caps warmer Receives: Procedure: composite restoration |
| incremental heated | Experimental | application of composite in increments after being heated by caps warmer Receives: Procedure: composite restoration |
| flowable | Experimental | application of flowable composite in non carious cervical lesions Receives: Procedure: composite restoration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention
ability of resin composite restorations to be retained in the non carious cervical lesions
Measured: 18-24 months
Secondary outcomes (1)
marginal staining
will be assessed visually by blinded evaluator
Measured: 18-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start14 May 2022
- Primary completion14 Dec 2025 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RetentionStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aisha Ahmed Elbaz, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06393699
- Sponsor's protocol ID
- 969
- Status last verified
- Feb 2025
- First submitted
- 29 Aug 2023
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoration of Non-carious Cervical Lesions: The Effect of Different Resin Composites Bonded With A Universal Adhesive Utilizing Two Adhesion Approaches: A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT06393699
- Acronym / sponsor ID
- 969
- Conditions
- Retention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 14 May 2022 (actual)
- Primary completion
- 14 Dec 2025 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 1 May 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.
patients with non carious cervical lesions suffer from dentin sensitivity and presence of cavitations and gingival recession. Restoring these lesions with different composites and evaluation of restorations every 6 months will be done to know the effect of different composite types and consistencies in retention of restorations of such lesions.
Detailed description
A split-mouth randomized clinical trial (RCT), based on the adhesion strategy, will be held on 52 patients attending to the outpatient clinics of the department of operative dentistry, Faculty of Dentistry, Ain Shams University with 2 non-carious cervical lesions in each side. Patients included in this study are those who seek restorative treatment of non-carious cervical lesions (NCCLs) in premolars and canines, which are due to chemical and/or mechanical predisposing factors. An informed consent will be signed by all participants who will be allocated in this study before being involved in the study. Male and female patients will be selected according to the inclusion and exclusion criteria. The patients will be randomly assigned into 4 main groups (n=13 patients/group) according to the type of restorative material will be inserted. In each group, two adhesive approaches will be employed, either etch-and-rinse (E\&R) or self-etching (SE)approach. For each patient's mouth, one side will receive restorations with the etch-and-rinse approach (n=26 restorations/E\&R approach), while the other side will receive restorations using the self-etching approach (n=26 restorations/SE approach). This will result in a total of 208 restorations will be inserted in this study. A treatment follow-up will be performed every six months for two years to investigate the clinical performance of the different resin composite restorations/the two different adhesive approaches.
Restorations will be evaluated at baseline and every 6 months by two blinded examiners, who will not be involved in the study. During evaluation, the examiners will not be informed about the type of restoration used or the adhesive approach and will have a code for each patient and the restored tooth. Restorations will be evaluated according to the modified United State Public Health Service criteria (USPHS).(6,9,13,30) Primary outcome will be the retention of the restoration, but the following secondary outcomes as marginal discoloration and adaptation, anatomic form, secondary caries, texture, and postoperative sensitivity will be also evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| incremental | Experimental | Procedure: composite restorationapplication of increments of packable composite in non carious cervical lesions |
| bulk fill heated | Experimental | Procedure: composite restorationapplication of heated composite as bulk in the lesions without incrementation after heating with caps warmer |
| incremental heated | Experimental | Procedure: composite restorationapplication of composite in increments after being heated by caps warmer |
| flowable | Experimental | Procedure: composite restorationapplication of flowable composite in non carious cervical lesions |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients' age will range from 18 to 65 years.
- Presence of at least 2 NCCLs in one side.
- Patients with no medical condition could interfere with the routine dental care.
- Patients who will be able to attend for each recall visit.
- Patients with healthy periodontal tissues.
Key exclusion criteria (7 listed)
- Medically compromised patients.
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 |
|---|---|---|
| composite restorationdifferent types of resin composite restorations will be used to restore NCCL | Procedure or surgery | bulk fill heated, flowable, incremental, incremental heated |
Primary outcome
Retention
Time frame: 18-24 months
ability of resin composite restorations to be retained in the non carious cervical lesions
1 secondary outcome
marginal staining
Time frame: 18-24 months
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 27 Feb 2025.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing composite restoration in people with Retention, run by Ain Shams 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 6 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: looking for participants now, as of the sponsor's last update on 27 Feb 2025. 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?
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?
Contact Aisha Elbaz (01156686680, aishareda@dent.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention (time frame: 18-24 months). 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 27 Feb 2025.