Dental CariesNCT07552129
Injectable Bioactive Composite vs Hall Technique for Proximal Cavities in Primary Molars
A study testing giomer and hall technique in people with Dental Caries, run by Cairo University.
Trial summary
This randomized clinical trial compares the survival rate and clinical performance of injectable bioactive giomer composite restorations versus the Hall Technique for managing proximal carious lesions (ICDAS 3-4) in primary molars of children aged 3-8 years over a 12-month follow-up period. Read more about this study
- Who is it for?
- Ages 3 to 8 years
- Conditions the study is for
- Dental Caries
- What is being tested?
- giomer and hall technique
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Jul 2027
- 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 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- • Generally showing cooperative behaviour that could be managed by the operators.
- Willing to sign the informed consent.
- Accepts the follow-up period.
- Moderate to low caries risk according to cariogram application
- Posterior primary molar with proximal carious lesion with no sign and symptoms of pulpal involvement.
- Radiographically (bitewing radiograph) extending to the outer1/3 of dentin
- ICDAS (3) and ICDAS(4).
Who cannot join
- • Allergy to any restorative materials.
- Patients undergoing orthodontic treatment with fixed appliances.
- Patients with debilitating systemic diseases.
- Children with special needs.
- Teeth with previous restorations.
- Periapical radiolucencies and sensitivity to axial or lateral percussion.
Show all 9Show fewer
- Mobile teeth.
- External or internal resorption.
- Cervical carious lesions.
About this study
Official title: Clinical Evaluation of Injectable Bioactive Composites vs Hall Technique for Restoring Proximal Cavities in Primary Molars: A Randomized Clinical Trial
This randomized clinical trial compares the survival rate and clinical performance of injectable bioactive giomer composite restorations versus the Hall Technique for managing proximal carious lesions (ICDAS 3-4) in primary molars of children aged 3-8 years over a 12-month follow-up period.
Read the detailed description
Children aged 3-8 years with proximal carious lesions in primary molars will be randomly assigned to receive either an injectable bioactive giomer restoration (Beautifil Flow Plus X, Shofu) or a Hall Technique preformed metal crown. Clinical outcomes will be assessed at baseline, 3, 6, and 12 months using survival rate criteria (Innes et al., 2007) and FDI criteria for biological properties.
- Conditions
- Dental Caries
- Being tested
- giomer, hall technique
- Keywords
- hall technique, giomer, primary molars, proximal cavities
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
giomerOther
restoration of proximal cavities in primary molars using an injectable bioactive composite (Giomer) material. Cavities will be prepared following minimally invasive principles, isolated appropriately, and restored according to the manufacturer's instructions using adhesive bonding. Clinical performance will be evaluated in terms of retention, marginal adaptation, secondary caries, postoperative sensitivity, and overall restoration success during the follow-up period.
hall techniqueOther
the hall technique is a minimally invasive method used in paediatric dentistry to manage carious primary molars.it involves sealing the decay under e preformed stainless steel crown
| Study group | Role | What they receive |
|---|---|---|
| Hall Technique | Active comparator | Preformed metal crown (stainless steel) placed over the carious primary molar using the Hall Technique, without caries removal or local anesthesia. A separator will be placed 48 hours prior to the procedure to create space for crown seating. The crown will be cemented with glass ionomer cement (GC Fuji I or equivalent) and seated with firm biting pressure. Receives: Other: hall technique |
| Giomer Restoration | Experimental | Proximal cavity preparation using a high-speed handpiece followed by selective caries removal. Isolation with cotton rolls and sectional matrix system. Application of bioactive self-etch adhesive (BeautiBond Xtreme, Shofu) followed by incremental placement of injectable bioactive giomer composite (Beautifil Flow Plus X F00, Shofu). Each increment light-cured for 20 seconds at 1000-1200 mW/cm². Finishing and polishing performed with fine diamond burs, finishing strips, and polishing discs. Receives: Other: giomer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Restoration Survival Rate assessed by clinical and radiographic success/failure criteria (Innes et al., 2007)
Measured: 1- year
Secondary outcomes (1)
FDI criteria biological
Biological properties: recurrent caries and adjacent mucosa
Measured: 1- year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by Cairo 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
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Menatalla Osama Shawkat Mohamed Ali, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07552129
- Sponsor's protocol ID
- CairoU- Hall Vs Giomer
- Other IDs
- Cairo University
- Status last verified
- Apr 2026
- First submitted
- 18 Feb 2026
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Injectable Bioactive Composites vs Hall Technique for Restoring Proximal Cavities in Primary Molars: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07552129
- Acronym / sponsor ID
- CairoU- Hall Vs Giomer
- Conditions
- Dental Caries
- Keywords
- hall technique, giomer, primary molars, proximal cavities
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 27 Apr 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.
This randomized clinical trial compares the survival rate and clinical performance of injectable bioactive giomer composite restorations versus the Hall Technique for managing proximal carious lesions (ICDAS 3-4) in primary molars of children aged 3-8 years over a 12-month follow-up period.
Detailed description
Children aged 3-8 years with proximal carious lesions in primary molars will be randomly assigned to receive either an injectable bioactive giomer restoration (Beautifil Flow Plus X, Shofu) or a Hall Technique preformed metal crown. Clinical outcomes will be assessed at baseline, 3, 6, and 12 months using survival rate criteria (Innes et al., 2007) and FDI criteria for biological properties.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hall Technique | Active comparator | Other: hall techniquePreformed metal crown (stainless steel) placed over the carious primary molar using the Hall Technique, without caries removal or local anesthesia. A separator will be placed 48 hours prior to the procedure to create space for crown seating. The crown will be cemented with glass ionomer cement (GC Fuji I or equivalent) and seated with firm biting pressure. |
| Giomer Restoration | Experimental | Other: giomerProximal cavity preparation using a high-speed handpiece followed by selective caries removal. Isolation with cotton rolls and sectional matrix system. Application of bioactive self-etch adhesive (BeautiBond Xtreme, Shofu) followed by incremental placement of injectable bioactive giomer composite (Beautifil Flow Plus X F00, Shofu). Each increment light-cured for 20 seconds at 1000-1200 mW/cm². Finishing and polishing performed with fine diamond burs, finishing strips, and polishing discs. |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- • Generally showing cooperative behaviour that could be managed by the operators.
Key exclusion criteria (9 listed)
- • Allergy to any restorative materials.
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 |
|---|---|---|
| giomerrestoration of proximal cavities in primary molars using an injectable bioactive composite (Giomer) material. Cavities will be prepared following minimally invasive principles, isolated appropriately, and restored according to the manufacturer's instructions using adhesive bonding. Clinical performance will be evaluated in terms of retention, marginal adaptation, secondary caries, postoperative sensitivity, and overall restoration success during the follow-up period. | Other | Giomer Restoration |
| hall techniquethe hall technique is a minimally invasive method used in paediatric dentistry to manage carious primary molars.it involves sealing the decay under e preformed stainless steel crown | Other | Hall Technique |
Primary outcome
Restoration Survival Rate assessed by clinical and radiographic success/failure criteria (Innes et al., 2007)
Time frame: 1- year
1 secondary outcome
FDI criteria biological
Time frame: 1- year
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 27 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Dental Caries
Not yet recruiting
Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities
Dental Caries, Cavity, Dental
Not yet recruiting
Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
Dental Caries, Dental Plaque
Recruiting
Oral Health Intervention in Adult Primary Care
Dental Caries, Dry Mouth
Not yet recruiting
The Effect of Bitewing Radiography on Outcomes and Costs of Treating Caries in Permanent Teeth
Dental Caries, Teeth Loss
Not yet recruiting
This Feasibility Study Will Evaluate the Study Protocols for Treatment and Follow-up Controls of Primary Molars With Caries in Children Treated With Stainless Steel Crowns or Conventional Fillings. Treatment Success and Potential Failures Will be Followed at 3, 6 and 12 Months Post Treatment.
Dental Caries, Early Childhood Caries (ECC)
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.
Questions about this trial
What is this clinical trial studying?
A study testing giomer and hall technique in people with Dental Caries, run by Cairo University.
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 9 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: opening soon, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Restoration Survival Rate assessed by clinical and radiographic success/failure criteria (Innes et al., 2007) (time frame: 1- year). 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 27 Apr 2026; AzTrials last refreshed its copy on 29 Oct 2026.