Noncarious Cervical LesionsNCT05533255
Preheated Composites Vs. Conventional Composites in Noncarious Cervical Lesions
A study testing Conventional composite resin (3M™ Filtek™ Z350 XT Universal Restorative) and Preheated composite resin (3M™ Filtek™ Z350 XT Universal Restorative) in people with Noncarious Cervical Lesions, run by Manipal University College Malaysia at 1 site in Malaysia.
Trial summary
Preheating resin composites is the warming of resin composites by using a heating device (composite warmer) before its placement. Preheating increases the flow properties and allows better adaptation to cavity preparation. The high thermal energy also improves polymerization rate, thereby reducing microleakage. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Noncarious Cervical Lesions
- What is being tested?
- Conventional composite resin (3M™ Filtek™ Z350 XT Universal Restorative) and Preheated composite resin (3M™ Filtek™ Z350 XT Universal Restorative)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteMalaysia
- Study dates
- 30 Jun 2022to 30 Jun 2023
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who are systemically healthy (ASA I and ASA II )44 and have satisfactory oral hygiene (OHI-S score of 0 to 3.0).
- Participants must have two noncarious cervical lesions (abrasion/abfraction), each on a canine, 1st premolar, 2nd premolar or 1st molar on the contralateral side of same dental arch (maxillary arch) with similar depth and width.
- Both NCCLs are in contact with antagonist teeth as well.
Who cannot join
- Participants requiring dental prostheses of the target teeth.
- Participants have a diagnosis of caries coincident with the cervical lesion, or an indication for irreversible endodontic treatment of the target teeth.
- Existence of periodontal damage with respect to the target teeth.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
Manipal University College Malaysia
Malacca, 75150
Anchu R Thomas, +601127292297, rachel.thomas@manipal.edu.my
About this study
Official title: Clinical Evaluation of Preheated Resin Composites Compared With Conventional Resin Composites in the Treatment of Noncarious Cervical Lesions - A Randomised Controlled Trial
Preheating resin composites is the warming of resin composites by using a heating device (composite warmer) before its placement. Preheating increases the flow properties and allows better adaptation to cavity preparation. The high thermal energy also improves polymerization rate, thereby reducing microleakage. Conventional composites resin is used as one-paste light-cured systems, which are built up in increments to overcome the effects of setting shrinkage and to ensure thorough curing.
Several studies report failure of cervical restorations of noncarious cervical lesions and an incessant search for the most suitable restorative material. Therefore, this study aims to evaluate the clinical performance of conventional resin composites compared with preheated resin composites in the treatment of noncarious cervical lesions. Our null hypothesis states that there is no difference between the clinical performance of preheated resin composites and conventional resin composites in the treatment of noncarious cervical lesions.
This study will be conducted at the Conservative and Endodontics Department in Polyclinic B, Faculty of Dentistry, Manipal University College Malaysia (MUCM). It involves forty-six randomly selected patients with two similar noncarious cervical lesions, each on a canine, first premolar, second premolar or first molar on the contralateral side of the maxillary arch. One lesion will be restored with preheated resin composite (3M™ Filtek™ Z350 XT Universal Restorative) while the other lesion will be restored with conventional resin composite (3M™ Filtek™ Z350 XT Universal Restorative). Both restorations will be done on each patient's first visit. The patients will be recalled 1,3 and 6 months later for assessment of the restorations, using modified US Public Health Service (USPHS) criteria: marginal integrity, marginal discoloration, wear, retention, secondary caries and postoperative sensitivity.
- Conditions
- Noncarious Cervical Lesions
- Being tested
- Conventional composite resin (3M™ Filtek™ Z350 XT Universal Restorative), Preheated composite resin (3M™ Filtek™ Z350 XT Universal Restorative)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional composite resin (3M™ Filtek™ Z350 XT Universal Restorative)Other
Composite resin at room temperature is used.
Preheated composite resin (3M™ Filtek™ Z350 XT Universal Restorative)Other
Conventional composite resin (3M™ Filtek™ Z350 XT Universal Restorative) is preheated to a temperature of 57 degrees Celsius using a composite warmer for 10 minutes is used.
| Study group | Role | What they receive |
|---|---|---|
| Preheated Resin Composites | Experimental | Preheated resin composite is placed on the noncarious cervical lesion of a canine/ first premolar/ second premolar/ first molar on either one quadrant of the maxillary arch. Receives: Other: Preheated composite resin (3M™ Filtek™ Z350 XT Universal Restorative) |
| Conventional Resin Composites | Active comparator | Conventional resin composite is placed on the noncarious cervical lesion of a canine/ first premolar/ second premolar/ first molar on the other quadrant of the maxillary arch. Receives: Other: Conventional composite resin (3M™ Filtek™ Z350 XT Universal Restorative) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Evaluation of Preheated Resin Composite Compared with Conventional Resin Composite
The restorations are evaluated using the modified US Public Health Service (USPHS) criteria
Measured: 1 month
Clinical Evaluation of Preheated Resin Composite Compared with Conventional Resin Composite
The restorations are evaluated using the modified US Public Health Service (USPHS) criteria
Measured: 3 month
Clinical Evaluation of Preheated Resin Composite Compared with Conventional Resin Composite
The restorations are evaluated using the modified US Public Health Service (USPHS) criteria
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start30 Jun 2022
- Primary completion31 Dec 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Noncarious Cervical LesionsStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Manipal University College Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Anchu Rachel Thomas, Manipal University College Malaysia
- Investigators
- Sy Ying Heng, Principal investigator, Manipal University College MalaysiaSze Yee Tan, Principal investigator, Manipal University College MalaysiaChi Rou Tee, Principal investigator, Manipal University College MalaysiaKrystell Chiu Yan Lau, Principal investigator, Manipal University College Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05533255
- Sponsor's protocol ID
- MUCM/FOD/AR/B10/E C-2022 (04)
- Status last verified
- Sep 2022
- First submitted
- 16 Jul 2022
- Last updated
- 8 Sep 2022
- Results posted
- 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 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Preheated Resin Composites Compared With Conventional Resin Composites in the Treatment of Noncarious Cervical Lesions - A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05533255
- Acronym / sponsor ID
- MUCM/FOD/AR/B10/E C-2022 (04)
- Conditions
- Noncarious Cervical Lesions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Manipal University College MalaysiaUniversity, hospital or other
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 8 Sep 2022 (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.
Preheating resin composites is the warming of resin composites by using a heating device (composite warmer) before its placement. Preheating increases the flow properties and allows better adaptation to cavity preparation. The high thermal energy also improves polymerization rate, thereby reducing microleakage. Conventional composites resin is used as one-paste light-cured systems, which are built up in increments to overcome the effects of setting shrinkage and to ensure thorough curing.
Several studies report failure of cervical restorations of noncarious cervical lesions and an incessant search for the most suitable restorative material. Therefore, this study aims to evaluate the clinical performance of conventional resin composites compared with preheated resin composites in the treatment of noncarious cervical lesions. Our null hypothesis states that there is no difference between the clinical performance of preheated resin composites and conventional resin composites in the treatment of noncarious cervical lesions.
This study will be conducted at the Conservative and Endodontics Department in Polyclinic B, Faculty of Dentistry, Manipal University College Malaysia (MUCM). It involves forty-six randomly selected patients with two similar noncarious cervical lesions, each on a canine, first premolar, second premolar or first molar on the contralateral side of the maxillary arch. One lesion will be restored with preheated resin composite (3M™ Filtek™ Z350 XT Universal Restorative) while the other lesion will be restored with conventional resin composite (3M™ Filtek™ Z350 XT Universal Restorative). Both restorations will be done on each patient's first visit. The patients will be recalled 1,3 and 6 months later for assessment of the restorations, using modified US Public Health Service (USPHS) criteria: marginal integrity, marginal discoloration, wear, retention, secondary caries and postoperative sensitivity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preheated Resin Composites | Experimental | Other: Preheated composite resin (3M™ Filtek™ Z350 XT Universal Restorative)Preheated resin composite is placed on the noncarious cervical lesion of a canine/ first premolar/ second premolar/ first molar on either one quadrant of the maxillary arch. |
| Conventional Resin Composites | Active comparator | Other: Conventional composite resin (3M™ Filtek™ Z350 XT Universal Restorative)Conventional resin composite is placed on the noncarious cervical lesion of a canine/ first premolar/ second premolar/ first molar on the other quadrant of the maxillary arch. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who are systemically healthy (ASA I and ASA II )44 and have satisfactory oral hygiene (OHI-S score of 0 to 3.0).
- Participants must have two noncarious cervical lesions (abrasion/abfraction), each on a canine, 1st premolar, 2nd premolar or 1st molar on the contralateral side of same dental arch (maxillary arch) with similar depth and width.
- Both NCCLs are in contact with antagonist teeth as well.
Key exclusion criteria (3 listed)
- Participants requiring dental prostheses of the target teeth.
- Participants have a diagnosis of caries coincident with the cervical lesion, or an indication for irreversible endodontic treatment of the target teeth.
- Existence of periodontal damage with respect to the target teeth.
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 |
|---|---|---|
| Conventional composite resin (3M™ Filtek™ Z350 XT Universal Restorative)Composite resin at room temperature is used. | Other | Conventional Resin Composites |
| Preheated composite resin (3M™ Filtek™ Z350 XT Universal Restorative)Conventional composite resin (3M™ Filtek™ Z350 XT Universal Restorative) is preheated to a temperature of 57 degrees Celsius using a composite warmer for 10 minutes is used. | Other | Preheated Resin Composites |
Primary outcome
Clinical Evaluation of Preheated Resin Composite Compared with Conventional Resin Composite
Time frame: 1 month
The restorations are evaluated using the modified US Public Health Service (USPHS) criteria
Clinical Evaluation of Preheated Resin Composite Compared with Conventional Resin Composite
Time frame: 3 month
The restorations are evaluated using the modified US Public Health Service (USPHS) criteria
Clinical Evaluation of Preheated Resin Composite Compared with Conventional Resin Composite
Time frame: 6 month
The restorations are evaluated using the modified US Public Health Service (USPHS) criteria
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
- Individual participant dataSharing planned: No
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.
Sy Ying Heng principal investigator
Manipal University College Malaysia
Sze Yee Tan principal investigator
Manipal University College Malaysia
Chi Rou Tee principal investigator
Manipal University College Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional composite resin (3M™ Filtek™ Z350 XT Universal Restorative) and Preheated composite resin (3M™ Filtek™ Z350 XT Universal Restorative) in people with Noncarious Cervical Lesions, run by Manipal University College Malaysia at 1 site in Malaysia.
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 3 inclusion and 3 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 8 Sep 2022. 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 Malaysia. 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?
Contact Anchu R Thomas (+601127292297, rachel.thomas@manipal.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Evaluation of Preheated Resin Composite Compared with Conventional Resin Composite (time frame: 1 month). The study lists 3 primary outcomes in all. 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 8 Sep 2022.