Dental Restorations, PermanentNCT05567263
Post-operative Sensitivity of a Self-adhesive Restorative Material
A study testing Bulk-fill resin composite, (3M, ESPE) and Surefil one™ Self-Adhesive Composite Hybrid in people with Dental Restorations, Permanent, run by King Abdullah University Hospital at 1 site in Jordan.
Trial summary
Adhesively restoring teeth using a resin-based composite and a modern dental adhesive is now considered a reliable, predictable, and durable procedure. However, adhering resin-based composite in conditions of suboptimal field control or complex cavity configurations remains challenging. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Restorations, Permanent
- What is being tested?
- Bulk-fill resin composite, (3M, ESPE) and Surefil one™ Self-Adhesive Composite Hybrid
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteJordan
- Study dates
- 1 Jan 2022to 30 Jun 2024
- 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
- Patient is at least 18 years' old
- Teeth are vital
- Teeth are periodontal healthy
- Tooth to be restored in normal occlusion with natural antagonist and adjacent teeth
- Patient did not receive orthodontic treatment
- Good level of oral hygiene.
Who cannot join
- Non-vital or endodontically treated teeth
- (Profound, chronic) periodontitis
- Deep carious defects (close to pulp, < 1mm distance)
- Heavy occlusal contacts or history of bruxism
- Poor oral hygiene
- Sustained dentin hypersensitivity
- Taking anti-inflammatory, analgesic, or psychotropic drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-operative Sensitivity and Clinical Performance of a Self-adhesive Restorative Material in Posterior Restorations.
Adhesively restoring teeth using a resin-based composite and a modern dental adhesive is now considered a reliable, predictable, and durable procedure. However, adhering resin-based composite in conditions of suboptimal field control or complex cavity configurations remains challenging. In addition, the continuing discussions on the clinical use of dental amalgam and the feasibility of a phase out of the use of dental amalgam in the long term has become a central concern for restorative dentistry and has led to strong efforts to develop a substitute material for amalgam. With the goal of clinically shorter application times and lower technique sensitivity, the development of an advanced self-adhesive restorative tooth-colored restorative materials (ASAR) that no longer need pre-treatment with a separate adhesive have been under investigation. The aim of this study is to assess the post-operative sensitivity following restoration of teeth using a self-adhesive tooth-colored restorative material and to assess its clinical performance in comparison with conventional resin-based composite in posterior restorations
- Conditions
- Dental Restorations, Permanent
- Being tested
- Bulk-fill resin composite, (3M, ESPE), Surefil one™ Self-Adhesive Composite Hybrid
- Keywords
- Composite, self-adhesive, sensetivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bulk-fill resin composite, (3M, ESPE)Procedure or surgery
Teeth will be restored with Bulk-fill resin composite, (3M, ESPE)
Surefil one™ Self-Adhesive Composite HybridProcedure or surgery
teeth will be restored with Surefil one™ Self-Adhesive Composite Hybrid
| Study group | Role | What they receive |
|---|---|---|
| Bulk- Fill | Active comparator | Restorative procedure of the teeth will be performed using Filtek-Bulk Fill Posterior Restorative, Bulk-fill resin composite, (3M, ESPE) following application of an etch-and-rinse single bottle adhesive (3M, ESPE). Receives: Procedure: Bulk-fill resin composite, (3M, ESPE) |
| Surefill One | Experimental | Restorative procedure of the teeth will be performed using Surefil one™ Self-Adhesive Composite Hybrid (Dentsply, Sirona), Receives: Procedure: Surefil one™ Self-Adhesive Composite Hybrid |
What is being measured
The primary outcome is the main question the study is designed to answer.
The post-operative sensitivity.
For the evaluation of post-operative sensitivity, participants will be asked to record whether they experienced sensitivity using a 0-4 numerical rating scale (0 = none, 1 = mild, 2 = moderate, 3 = considerable, and 4 = severe). The patients will be asked to fill in the pain scale forms 24 hours after the restorative procedure and daily up to seven days, and at 2 weeks and 1 month intervals.
Measured: One month after the treatment.
Secondary outcomes (1)
Clinical performance of the restorations
All restorations will be evaluated at 6 months and 1-year post-restoration using the United States Public Health Service, USPHS criteria using the Alpha, Bravo and Charlie scale to evaluate the following parameters: retention, color match, marginal discoloration, secondary caries, anatomical form, marginal adaptation, and surface roughness.
Measured: 6 months and 1 year after the treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start1 Jan 2022
- Primary completion30 Mar 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental Restorations, PermanentStudies 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
- Parallel groups
- Model description
- The design of study will be a split-mouth randomized clinical trial with two study groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdullah University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jordan University of Science and Technology
- Responsible party
- Principal investigator, Ghada Maghaireh, King Abdullah University Hospital
- Investigators
- Ghada A Maghaireh, Principal investigator, Jordan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05567263
- Sponsor's protocol ID
- 20210419
- Status last verified
- Jul 2024
- First submitted
- 3 Oct 2022
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maghaireh GA, Albashaireh ZS, Allouz HA. Postoperative sensitivity in posterior restorations restored with self-adhesive and conventional bulk-fill resin composites: A randomized clinical split-mouth trial. J Dent. 2023 Oct;137:104655. doi: 10.1016/j.jdent.2023.104655. Epub 2023 Aug 9.
PubMed 37562757
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-operative Sensitivity and Clinical Performance of a Self-adhesive Restorative Material in Posterior Restorations.
- ClinicalTrials.gov ID
- NCT05567263
- Acronym / sponsor ID
- 20210419
- Conditions
- Dental Restorations, Permanent
- Keywords
- Composite, self-adhesive, sensetivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- King Abdullah University HospitalUniversity, hospital or other
- Collaborators
- Jordan University of Science and Technology
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 5 Oct 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.
Adhesively restoring teeth using a resin-based composite and a modern dental adhesive is now considered a reliable, predictable, and durable procedure. However, adhering resin-based composite in conditions of suboptimal field control or complex cavity configurations remains challenging. In addition, the continuing discussions on the clinical use of dental amalgam and the feasibility of a phase out of the use of dental amalgam in the long term has become a central concern for restorative dentistry and has led to strong efforts to develop a substitute material for amalgam. With the goal of clinically shorter application times and lower technique sensitivity, the development of an advanced self-adhesive restorative tooth-colored restorative materials (ASAR) that no longer need pre-treatment with a separate adhesive have been under investigation. The aim of this study is to assess the post-operative sensitivity following restoration of teeth using a self-adhesive tooth-colored restorative material and to assess its clinical performance in comparison with conventional resin-based composite in posterior restorations
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The design of study will be a split-mouth randomized clinical trial with two study groups.
| Arm | Type | Receives |
|---|---|---|
| Bulk- Fill | Active comparator | Procedure: Bulk-fill resin composite, (3M, ESPE)Restorative procedure of the teeth will be performed using Filtek-Bulk Fill Posterior Restorative, Bulk-fill resin composite, (3M, ESPE) following application of an etch-and-rinse single bottle adhesive (3M, ESPE). |
| Surefill One | Experimental | Procedure: Surefil one™ Self-Adhesive Composite HybridRestorative procedure of the teeth will be performed using Surefil one™ Self-Adhesive Composite Hybrid (Dentsply, Sirona), |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient is at least 18 years' old
- Teeth are vital
- Teeth are periodontal healthy
- Tooth to be restored in normal occlusion with natural antagonist and adjacent teeth
- Patient did not receive orthodontic treatment
Key exclusion criteria (7 listed)
- Non-vital or endodontically treated teeth
- (Profound, chronic) periodontitis
- Deep carious defects (close to pulp, < 1mm distance)
- Heavy occlusal contacts or history of bruxism
- Poor oral hygiene
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 |
|---|---|---|
| Bulk-fill resin composite, (3M, ESPE)Teeth will be restored with Bulk-fill resin composite, (3M, ESPE) | Procedure or surgery | Bulk- Fill |
| Surefil one™ Self-Adhesive Composite Hybridteeth will be restored with Surefil one™ Self-Adhesive Composite Hybrid | Procedure or surgery | Surefill One |
Primary outcome
The post-operative sensitivity.
Time frame: One month after the treatment.
For the evaluation of post-operative sensitivity, participants will be asked to record whether they experienced sensitivity using a 0-4 numerical rating scale (0 = none, 1 = mild, 2 = moderate, 3 = considerable, and 4 = severe). The patients will be asked to fill in the pain scale forms 24 hours after the restorative procedure and daily up to seven days, and at 2 weeks and 1 month intervals.
1 secondary outcome
Clinical performance of the restorations
Time frame: 6 months and 1 year after the treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Derived from this study: PubMed 37562757Maghaireh GA, Albashaireh ZS, Allouz HA. Postoperative sensitivity in posterior restorations restored with self-adhesive and conventional bulk-fill resin composites: A randomized clinical split-mouth trial. J Dent. 2023 Oct;137:104655. doi: 10.1016/j.jdent.2023.104655. Epub 2023 Aug 9.
- Individual participant dataSharing planned: No
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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.
Ghada A Maghaireh principal investigator
Jordan University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bulk-fill resin composite, (3M, ESPE) and Surefil one™ Self-Adhesive Composite Hybrid in people with Dental Restorations, Permanent, run by King Abdullah University Hospital at 1 site in Jordan.
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: finished, as of the sponsor's last update on 12 Jul 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 Jordan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The post-operative sensitivity. (time frame: One month after the treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05567263, which also lists 1 linked publication.
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 12 Jul 2024.