Carious LesionNCT07640074
Clinical Performance of Novel Coconut Based Restorative Material.
A study testing Nano-reinforced glass ionomer and glass ionomer without nanoparicles in people with Carious Lesion and Restoration, run by Pakistan Institute of Medical Sciences at 1 site in Pakistan.
Trial summary
A triple-blind, parallel group, randomized trial with an allocation ratio of 1:1. Participants randomly allocated into two groups A and B. In group A, nano-reinforced glass ionomer restoration will be utilized while in group B, glass ionomer restoration without nanoparticles was used. Read more about this study
- Who is it for?
- Ages 5 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Carious Lesion, Restoration
- What is being tested?
- Nano-reinforced glass ionomer and glass ionomer without nanoparicles
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2026to 1 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 5 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The inclusion criteria shall consider patients from Pediatric Department of hospital between 5 and 9 years of age having either sex with primary teeth requiring restorations of Class I cavities followed by parent or guardian informed consent.
Who cannot join
- The exclusion criteria will include teeth with pathology, pulp exposure, uncooperative patients where treatment could not be performed, and patients with inadequate oral hygiene.
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: Clinical Performance of Novel Coconut Based Restorative Material in the Primary Dentition.
A triple-blind, parallel group, randomized trial with an allocation ratio of 1:1. Participants randomly allocated into two groups A and B. In group A, nano-reinforced glass ionomer restoration will be utilized while in group B, glass ionomer restoration without nanoparticles was used. Parameters of clinical performance measured will be: A. Surface structure B. Anatomical shape C. marginal adhesion. Clinical performance of Restorations will be assessed with4-level Ryge's scale at baseline, after 1, 3 and 6 months. The numerical Ryge's scale will be used for comparison of quality of restoration in subsequent control clinical examinations and tracking its changes over time. Parameters will be evaluated on standardized scale 0-3. Restorations that will be rated 0 (very good - ideal condition) and 1 (satisfying - requiring minor corrections) will be considered clinically acceptable. Restorations with rating 2 (need for deferred replacement of the restoration) or 3 (unacceptable - restoration needs to be replaced immediately) will be considered clinically unacceptable.
Read the detailed description
This triple-blind parallel group, randomized clinical trial will be conducted at the department of Operative Dentistry and Endodontics, School of Dentistry from June 1 2026, to November 1, 2026. Participants will be randomly distributed into two groups by Lottery method. A consecutive non-probability sampling technique will be used. Before initiating treatment, participants will be briefed about the intervention. In both groups, Isolate the tooth absolutely or relatively as needed. Excavate carious tissue from interproximal, cervical, or occlusal surfaces (for interproximal restorations, place a celluloid matrix band after cavity preparation). Apply 2.25% sodium hypochlorite (one minute application time). Rinse thoroughly for 10 seconds. Condition the cavity with GIC liquid conditioner. Prepare the material at a 1:1 powder-to-liquid ratio. Bulk-fill the cavity with the mixed GIC. Anatomically contour to restore tooth morphology. Verify and adjust occlusion. In group A, Nano-reinforced glass ionomer restorative material will be placed while in group B, glass ionomer restorative material without nanoparticles will be utilized. Parameters of clinical performance measured will be: A. Surface structure ( colour, smoothness, gloss, discolouration) B. Anatomical shape (restoration of anatomical shape, nodules and shear surface) C. marginal adhesion (presence of a marginal fissure, discolouration, cracks, damage to the edges of the filling, secondary caries). Clinical performance of Restorations will be assessed with4-level Ryge's scale at baseline, after 1, 3 and 6 months for clinical performance. The numerical Ryge's scale allows for comparison of quality of restoration in subsequent control clinical examinations and tracking its changes over time. Parameters will be evaluated on standardized scale 0-3. Restorations that will be rated 0 (very good - ideal condition) and 1 (satisfying - requiring minor corrections) will be considered clinically acceptable. Restorations with rating 2 (need for deferred replacement of the restoration) or 3 (unacceptable - restoration needs to be replaced immediately) will be considered clinically unacceptable. Results will be analyzed statistically with the Cochran's Q test.
- Conditions
- Carious Lesion, Restoration
- Being tested
- Nano-reinforced glass ionomer, glass ionomer without nanoparicles
- Keywords
- Glass ionomer cement, Titania nanoparticles, Primary teeth
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nano-reinforced glass ionomerDrug
Group A (glass ionomer restoration reinforced with coconut derived- titania nanoparticles)
glass ionomer without nanopariclesDrug
Group B ( glass ionomer restoration without nanoparticles)
| Study group | Role | What they receive |
|---|---|---|
| Group A (Nano-reinforced glass ionomer) | Experimental | glass ionomer restoration reinforced with coconut derived- titania nanoparticles Receives: Drug: Nano-reinforced glass ionomer |
| Experimental: Group B (Conventional glass ionomer) | Experimental | glass ionomer restoration without nanoparticles Receives: Drug: glass ionomer without nanoparicles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure clinical behavior of restorations with the use of a 4-level Ryge's scale having 0-3 standardized scale. Parameters measured will be; 1. Surface structure 2-. Anatomical shape 3. marginal adhesion
Restorations will be assessed with4-level Ryge's scale at baseline, after 1, 3 and 6 months. The numerical Ryge's scale allows for comparison of quality of restoration in subsequent control clinical examinations and tracking its changes over time. Parameters will be evaluated on standardized scale 0-3. Restorations that were rated 0 (very good - ideal condition) and 1 (satisfying - requiring minor corrections) will be considered clinically acceptable. Restorations with rating 2 (need for deferred replacement of the restoration) or 3 (unacceptable - restoration needs to be replaced immediately) were considered clinically unacceptable.Parameters measured will be:
- Surface structure ( colour, smoothness, gloss, discolouration) B. Anatomical shape (restoration of anatomical shape, nodules and shear surface) C. marginal adhesion (presence of a marginal fissure, discolouration, cracks, damage to the edges of the filling, secondary caries)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Dec 2026 (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 Carious LesionStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Medical Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Afsheen Mansoor, Pakistan Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07640074
- Sponsor's protocol ID
- SOD/ERD/2025/100
- Status last verified
- May 2026
- First submitted
- 26 May 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Padilla-Ocampo CA, Medecigo-Costeira D, Pioquinto-Mendoza JR, Navarrete-Hernandez JJ, Mendoza-Rodriguez M, Marquez-Corona ML, Villalobos-Rodelo JJ, Casanova-Rosado JF, Medina-Solis CE, Maupome G. Short-Term Assessment of Cention N vs. Glass Ionomer Cement (Fuji IX) as a Definitive Restoration in the Primary Dentition of Mexican Children: A Pilot Study. Cureus. 2025 May 9;17(5):e83784. doi: 10.7759/cureus.83784. eCollection 2025 May.
PubMed 40491641
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Novel Coconut Based Restorative Material in the Primary Dentition.
- ClinicalTrials.gov ID
- NCT07640074
- Acronym / sponsor ID
- SOD/ERD/2025/100
- Conditions
- Carious Lesion, Restoration
- Keywords
- Glass ionomer cement, Titania nanoparticles, Primary teeth
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Pakistan Institute of Medical SciencesOther government
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 10 Jun 2026 (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.
A triple-blind, parallel group, randomized trial with an allocation ratio of 1:1. Participants randomly allocated into two groups A and B. In group A, nano-reinforced glass ionomer restoration will be utilized while in group B, glass ionomer restoration without nanoparticles was used. Parameters of clinical performance measured will be: A. Surface structure B. Anatomical shape C. marginal adhesion. Clinical performance of Restorations will be assessed with4-level Ryge's scale at baseline, after 1, 3 and 6 months. The numerical Ryge's scale will be used for comparison of quality of restoration in subsequent control clinical examinations and tracking its changes over time. Parameters will be evaluated on standardized scale 0-3. Restorations that will be rated 0 (very good - ideal condition) and 1 (satisfying - requiring minor corrections) will be considered clinically acceptable. Restorations with rating 2 (need for deferred replacement of the restoration) or 3 (unacceptable - restoration needs to be replaced immediately) will be considered clinically unacceptable.
Detailed description
This triple-blind parallel group, randomized clinical trial will be conducted at the department of Operative Dentistry and Endodontics, School of Dentistry from June 1 2026, to November 1, 2026. Participants will be randomly distributed into two groups by Lottery method. A consecutive non-probability sampling technique will be used. Before initiating treatment, participants will be briefed about the intervention. In both groups, Isolate the tooth absolutely or relatively as needed. Excavate carious tissue from interproximal, cervical, or occlusal surfaces (for interproximal restorations, place a celluloid matrix band after cavity preparation). Apply 2.25% sodium hypochlorite (one minute application time). Rinse thoroughly for 10 seconds. Condition the cavity with GIC liquid conditioner. Prepare the material at a 1:1 powder-to-liquid ratio. Bulk-fill the cavity with the mixed GIC. Anatomically contour to restore tooth morphology. Verify and adjust occlusion. In group A, Nano-reinforced glass ionomer restorative material will be placed while in group B, glass ionomer restorative material without nanoparticles will be utilized. Parameters of clinical performance measured will be: A. Surface structure ( colour, smoothness, gloss, discolouration) B. Anatomical shape (restoration of anatomical shape, nodules and shear surface) C. marginal adhesion (presence of a marginal fissure, discolouration, cracks, damage to the edges of the filling, secondary caries). Clinical performance of Restorations will be assessed with4-level Ryge's scale at baseline, after 1, 3 and 6 months for clinical performance. The numerical Ryge's scale allows for comparison of quality of restoration in subsequent control clinical examinations and tracking its changes over time. Parameters will be evaluated on standardized scale 0-3. Restorations that will be rated 0 (very good - ideal condition) and 1 (satisfying - requiring minor corrections) will be considered clinically acceptable. Restorations with rating 2 (need for deferred replacement of the restoration) or 3 (unacceptable - restoration needs to be replaced immediately) will be considered clinically unacceptable. Results will be analyzed statistically with the Cochran's Q test.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Nano-reinforced glass ionomer) | Experimental | Drug: Nano-reinforced glass ionomerglass ionomer restoration reinforced with coconut derived- titania nanoparticles |
| Experimental: Group B (Conventional glass ionomer) | Experimental | Drug: glass ionomer without nanopariclesglass ionomer restoration without nanoparticles |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- The inclusion criteria shall consider patients from Pediatric Department of hospital between 5 and 9 years of age having either sex with primary teeth requiring restorations of Class I cavities followed by parent or guardian informed consent.
Key exclusion criteria (1 listed)
- The exclusion criteria will include teeth with pathology, pulp exposure, uncooperative patients where treatment could not be performed, and patients with inadequate 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 |
|---|---|---|
| Nano-reinforced glass ionomerGroup A (glass ionomer restoration reinforced with coconut derived- titania nanoparticles) | Drug | Group A (Nano-reinforced glass ionomer) |
| glass ionomer without nanopariclesGroup B ( glass ionomer restoration without nanoparticles) | Drug | Experimental: Group B (Conventional glass ionomer) |
Primary outcome
Measure clinical behavior of restorations with the use of a 4-level Ryge's scale having 0-3 standardized scale. Parameters measured will be; 1. Surface structure 2-. Anatomical shape 3. marginal adhesion
Time frame: 6 months
Restorations will be assessed with4-level Ryge's scale at baseline, after 1, 3 and 6 months. The numerical Ryge's scale allows for comparison of quality of restoration in subsequent control clinical examinations and tracking its changes over time. Parameters will be evaluated on standardized scale 0-3. Restorations that were rated 0 (very good - ideal condition) and 1 (satisfying - requiring minor corrections) will be considered clinically acceptable. Restorations with rating 2 (need for deferred replacement of the restoration) or 3 (unacceptable - restoration needs to be replaced immediately) were considered clinically unacceptable.Parameters measured will be: A. Surface structure ( colour, smoothness, gloss, discolouration) B. Anatomical shape (restoration of anatomical shape, nodules and shear surface) C. marginal adhesion (presence of a marginal fissure, discolouration, cracks, damage to the edges of the filling, secondary caries)
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 10 Jun 2026.
- Background: PubMed 40491641Padilla-Ocampo CA, Medecigo-Costeira D, Pioquinto-Mendoza JR, Navarrete-Hernandez JJ, Mendoza-Rodriguez M, Marquez-Corona ML, Villalobos-Rodelo JJ, Casanova-Rosado JF, Medina-Solis CE, Maupome G. Short-Term Assessment of Cention N vs. Glass Ionomer Cement (Fuji IX) as a Definitive Restoration in the Primary Dentition of Mexican Children: A Pilot Study. Cureus. 2025 May 9;17(5):e83784. doi: 10.7759/cureus.83784. eCollection 2025 May.
- 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.
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 Nano-reinforced glass ionomer and glass ionomer without nanoparicles in people with Carious Lesion and Restoration, run by Pakistan Institute of Medical Sciences at 1 site in Pakistan.
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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 10 Jun 2026. 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 Pakistan. 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?
Measure clinical behavior of restorations with the use of a 4-level Ryge's scale having 0-3 standardized scale. Parameters measured will be; 1. Surface structure 2-. Anatomical shape 3. marginal adhesion (time frame: 6 months). 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 NCT07640074, 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 10 Jun 2026.