Occlusal CariesNCT06803537
Three-Year Clinical Performance of Fiber-reinforced Versus Indirect Resin Composite Posterior Restorations
A study testing Fiber-reinforced composite, indirect lab composite and Conventional resin composite in people with Occlusal Caries and Proximal Caries, run by Mansoura University at 1 site in Egypt.
Trial summary
This study aimed to perform a comparison between the clinical performance of short fiber-reinforced composite and indirect lab composite restorations in posterior dentition. Read more about this study
- Who is it for?
- Ages 20 to 35 years
- Conditions the study is for
- Occlusal Caries, Proximal Caries
- What is being tested?
- Fiber-reinforced composite, indirect lab composite and Conventional resin composite
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to Jul 2025
- 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 20 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged 20-35 year from both genders.
- Good oral hygiene: patients with low and moderate caries risk (according to Caries management by caries risk assessment CAMBRA sheets) were enrolled in this study.
- The visual examination should reveal the presence of a minimum of three primary occlusal or proximal caries (Black Class I and II) with a severity score of 4 or 5 according to the International Caries Detection and Assessment System (ICDAS).
- The carious teeth must exhibit vitality and do not display periapical radiolucency as evaluated by periapical radiography.
- The selected teeth must be under stable occlusion.
Who cannot join
- Uncontrolled systemic disease
- Extremely poor oral hygiene
- Chronic periodontitis
- Heavy bruxism
- Cavities with a buccolingual width exceeding two-thirds of the intercuspal distance or requiring cusp covering.
- Patients undergoing orthodontic procedures.
- Patients unable to attend the scheduled recall appointments.
Trial locations and contacts
1 site in 1 country.
About this study
This study aimed to perform a comparison between the clinical performance of short fiber-reinforced composite and indirect lab composite restorations in posterior dentition.
- Conditions
- Occlusal Caries, Proximal Caries
- Being tested
- Fiber-reinforced composite, indirect lab composite, Conventional resin composite
- Keywords
- fiber-reinforced composite, indirect lab composite, posterior restorations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fiber-reinforced compositeOther
short fiber-reinforced composite used as base covered by conventional composite
indirect lab compositeOther
indirect lab processed resin composite inlay restorations
Conventional resin compositeOther
conventional microhybrid resin composite posterior restorations
| Study group | Role | What they receive |
|---|---|---|
| Fiber-reinforced composite | Active comparator | Not described Receives: Other: indirect lab composite; Other: Conventional resin composite |
| Indirect lab composite | Active comparator | Not described Receives: Other: Fiber-reinforced composite; Other: Conventional resin composite |
| Conventional microhybrid resin composite | Active comparator | Not described Receives: Other: Fiber-reinforced composite; Other: indirect lab composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
FDI criteria for evaluation
Measured: Three years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start1 Jan 2022
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
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 Occlusal CariesStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06803537
- Sponsor's protocol ID
- A02071221
- Status last verified
- Jan 2025
- First submitted
- 27 Jan 2025
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Salama RM, Hamama HH, Mahmoud SH. Clinical performance of short fiber-reinforced and indirect resin composites in class I and class II restorations: A three-year randomized clinical trial. Clin Oral Investig. 2025 Nov 21;29(12):580. doi: 10.1007/s00784-025-06593-x.
PubMed 41269396
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-Year Clinical Performance of Fiber-reinforced Versus Indirect Resin Composite Posterior Restorations
- ClinicalTrials.gov ID
- NCT06803537
- Acronym / sponsor ID
- A02071221
- Conditions
- Occlusal Caries, Proximal Caries
- Keywords
- fiber-reinforced composite, indirect lab composite, posterior restorations
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 31 Jan 2025 (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 study aimed to perform a comparison between the clinical performance of short fiber-reinforced composite and indirect lab composite restorations in posterior dentition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fiber-reinforced composite | Active comparator | Other: indirect lab composite, Other: Conventional resin composite |
| Indirect lab composite | Active comparator | Other: Fiber-reinforced composite, Other: Conventional resin composite |
| Conventional microhybrid resin composite | Active comparator | Other: Fiber-reinforced composite, Other: indirect lab composite |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients aged 20-35 year from both genders.
- Good oral hygiene: patients with low and moderate caries risk (according to Caries management by caries risk assessment CAMBRA sheets) were enrolled in this study.
- The visual examination should reveal the presence of a minimum of three primary occlusal or proximal caries (Black Class I and II) with a severity score of 4 or 5 according to the International Caries Detection and Assessment System (ICDAS).
- The carious teeth must exhibit vitality and do not display periapical radiolucency as evaluated by periapical radiography.
- The selected teeth must be under stable occlusion.
Key exclusion criteria (7 listed)
- Uncontrolled systemic disease
- Extremely poor oral hygiene
- Chronic periodontitis
- Heavy bruxism
- Cavities with a buccolingual width exceeding two-thirds of the intercuspal distance or requiring cusp covering.
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 |
|---|---|---|
| Fiber-reinforced compositeshort fiber-reinforced composite used as base covered by conventional composite | Other | Conventional microhybrid resin composite, Indirect lab composite |
| indirect lab compositeindirect lab processed resin composite inlay restorations | Other | Conventional microhybrid resin composite, Fiber-reinforced composite |
| Conventional resin compositeconventional microhybrid resin composite posterior restorations | Other | Fiber-reinforced composite, Indirect lab composite |
Primary outcome
FDI criteria for evaluation
Time frame: Three years follow-up
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 11 May 2025.
- Derived from this study: PubMed 41269396Salama RM, Hamama HH, Mahmoud SH. Clinical performance of short fiber-reinforced and indirect resin composites in class I and class II restorations: A three-year randomized clinical trial. Clin Oral Investig. 2025 Nov 21;29(12):580. doi: 10.1007/s00784-025-06593-x.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fiber-reinforced composite, indirect lab composite and Conventional resin composite in people with Occlusal Caries and Proximal Caries, run by Mansoura 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 5 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: under way, not looking for participants, as of the sponsor's last update on 11 May 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?
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?
FDI criteria for evaluation (time frame: Three years follow-up). 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 NCT06803537, 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 11 May 2025.