Composite RestorationNCT07243496
Composite Restoration of Class II Cavities in Primary Molars With or Without Pulpotomy. Prospective 24 Month Clinical Trial.
A study testing Class II restoration after pulpotomy and Class II restoration without pulpotomy in people with Composite Restoration and Primary Tooth Pulpotomy, run by Lygidakis Dental Clinic at 1 site in Greece.
Trial summary
After 24 months: Investigation of the success rate of Class II composite resin restorations in primary molars that have undergone pulpotomy. Comparison of Class II composite resin restorations in primary molars that have undergone pulpotomy with restorations of the same type in the same patient, in which no pulpotomy… Read more about this study
- Who is it for?
- Ages 3 to 9 years
- Conditions the study is for
- Composite Restoration, Primary Tooth Pulpotomy
- What is being tested?
- Class II restoration after pulpotomy and Class II restoration without pulpotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGreece
- Study dates
- 1 May 2024to 1 May 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 3 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Healthy children aged 3-9 years
- At least one pulpotomy in a carious primary molar requiring a Class II resin restoration
- At least one Class II cavity in a carious primary molar in the same patient that requires a resin restoration
- The teeth to be restored must not present clinical signs of pulp necrosis, such as pathological mobility or abscess/fistula
- Parents have signed an informed consent form
- The young patients return for evaluation at 12 and 24 months
- There is no exfoliation or extraction of the evaluated teeth before the 24-month period
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
After 24 months:
- Investigation of the success rate of Class II composite resin restorations in primary molars that have undergone pulpotomy.
- Comparison of Class II composite resin restorations in primary molars that have undergone pulpotomy with restorations of the same type in the same patient, in which no pulpotomy has been performed.
The null hypothesis of the study is that there is no statistically significant difference in the success of Class II resin restorations after their placement in primary molars, regardless of whether a pulpotomy has been performed or not.
- Conditions
- Composite Restoration, Primary Tooth Pulpotomy
- Being tested
- Class II restoration after pulpotomy, Class II restoration without pulpotomy
- Keywords
- class II cavity, primary tooth, pulpotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Class II restoration after pulpotomyProcedure or surgery
The same dentist performs all restorations. All treatments are carried out using a rubber dam and the appropriate local anesthesia. After pulpotomy completion with a layer of MTA®, an intermediate layer of glass ionomer cement (Vitrebond Plus™) is placed before the final composite resin restoration. Class II resin restorations are performed after complete caries removal, placement of a partial matrix, etching with 37% phosphoric acid for 15 seconds, bonding with a 4th-generation adhesive agent (Prime n Bond NT, Dentsply™), and placement of composite resin (Filtek Universal™, 3M™).
Class II restoration without pulpotomyProcedure or surgery
The same dentist performs all restorations. All treatments are carried out using a rubber dam and the appropriate local anesthesia. Class II resin restorations are performed after complete caries removal, placement of a partial matrix, etching with 37% phosphoric acid for 15 seconds, bonding with a 4th-generation adhesive agent (Prime n Bond NT, Dentsply™), and placement of composite resin (Filtek Universal™, 3M™).
| Study group | Role | What they receive |
|---|---|---|
| Class II composite restoration on primary teeth with pulpotomy | Active comparator | Not described Receives: Procedure: Class II restoration after pulpotomy |
| Class II composite restoration on primary teeth without pulpotomy | Active comparator | Not described Receives: Procedure: Class II restoration without pulpotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified USPHS criteria
Modified USPHS criteria are variations of the original United States Public Health Service criteria used in dentistry to clinically evaluate restorations. They include the following criteria: marginal adaptation, retention, marginal discoloration, and secondary caries, with specific parameters and scoring scales adjusted for a particular study or material being evaluated. These modifications allow for a more precise assessment of dental restorations by tailoring the evaluation to specific clinical situations or restorative materials
Measured: Assessment is done at 12 and 24 months following placement of the composite restoration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start1 May 2024
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Composite RestorationStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lygidakis Dental Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nikos Lygidakis, Lygidakis Dental Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07243496
- Sponsor's protocol ID
- 1495
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 24 Nov 2025
- 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 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Composite Restoration of Class II Cavities in Primary Molars With or Without Pulpotomy. Prospective 24 Month Clinical Trial.
- ClinicalTrials.gov ID
- NCT07243496
- Acronym / sponsor ID
- 1495
- Conditions
- Composite Restoration, Primary Tooth Pulpotomy
- Keywords
- class II cavity, primary tooth, pulpotomy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Lygidakis Dental ClinicUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 24 Nov 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.
After 24 months:
- Investigation of the success rate of Class II composite resin restorations in primary molars that have undergone pulpotomy.
- Comparison of Class II composite resin restorations in primary molars that have undergone pulpotomy with restorations of the same type in the same patient, in which no pulpotomy has been performed.
The null hypothesis of the study is that there is no statistically significant difference in the success of Class II resin restorations after their placement in primary molars, regardless of whether a pulpotomy has been performed or not.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Class II composite restoration on primary teeth with pulpotomy | Active comparator | Procedure: Class II restoration after pulpotomy |
| Class II composite restoration on primary teeth without pulpotomy | Active comparator | Procedure: Class II restoration without pulpotomy |
Who may qualify
- Ages
- 3 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Healthy children aged 3-9 years
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Class II restoration after pulpotomyThe same dentist performs all restorations. All treatments are carried out using a rubber dam and the appropriate local anesthesia. After pulpotomy completion with a layer of MTA®, an intermediate layer of glass ionomer cement (Vitrebond Plus™) is placed before the final composite resin restoration. Class II resin restorations are performed after complete caries removal, placement of a partial matrix, etching with 37% phosphoric acid for 15 seconds, bonding with a 4th-generation adhesive agent (Prime n Bond NT, Dentsply™), and placement of composite resin (Filtek Universal™, 3M™). | Procedure or surgery | Class II composite restoration on primary teeth with pulpotomy |
| Class II restoration without pulpotomyThe same dentist performs all restorations. All treatments are carried out using a rubber dam and the appropriate local anesthesia. Class II resin restorations are performed after complete caries removal, placement of a partial matrix, etching with 37% phosphoric acid for 15 seconds, bonding with a 4th-generation adhesive agent (Prime n Bond NT, Dentsply™), and placement of composite resin (Filtek Universal™, 3M™). | Procedure or surgery | Class II composite restoration on primary teeth without pulpotomy |
Primary outcome
Modified USPHS criteria
Time frame: Assessment is done at 12 and 24 months following placement of the composite restoration
Modified USPHS criteria are variations of the original United States Public Health Service criteria used in dentistry to clinically evaluate restorations. They include the following criteria: marginal adaptation, retention, marginal discoloration, and secondary caries, with specific parameters and scoring scales adjusted for a particular study or material being evaluated. These modifications allow for a more precise assessment of dental restorations by tailoring the evaluation to specific clinical situations or restorative materials
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 24 Nov 2025.
- 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.
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 Class II restoration after pulpotomy and Class II restoration without pulpotomy in people with Composite Restoration and Primary Tooth Pulpotomy, run by Lygidakis Dental Clinic at 1 site in Greece.
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 7 inclusion and 0 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 24 Nov 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 Greece. 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?
Modified USPHS criteria (time frame: Assessment is done at 12 and 24 months following placement of the composite restoration). 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 24 Nov 2025.