Dental CariesMiCRO-PMNCT07447583
Traditional vs. Minimally Invasive Decay Treatments in Primary Molars: An 18-month Split-mouth Randomized Study
A study testing Hall Technique, Silver diamine Fluoride 38% and Compomer Restoration in people with Dental Caries, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to compare the 18-month clinical success rates of three caries management approaches in primary molars of 60 healthy children aged 4-8 years attending the Department of Pediatric Dentistry at Erciyes University, using a randomized split-mouth design involving 180 treated teeth. Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Dental Caries
- What is being tested?
- Hall Technique, Silver diamine Fluoride 38% and Compomer Restoration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2024to 9 Feb 2026
- 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 4 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 4 to 8 years.
- Systemically healthy children without any medical or syndromic conditions.
- Frankl Behavior Rating Scale score of 3 (positive) or 4 (definitely positive).
- Presence of at least three unrestored, asymptomatic primary molars with active occluso-proximal dentine caries lesions (ICDAS codes 3, 4, or 5).
- Written informed consent obtained from parents or legal guardians, with willingness to attend follow-up visits.
Who cannot join
- Refusal to provide informed consent or unwillingness to participate.
- Presence of systemic disease or chronic medical conditions requiring special care or antibiotic prophylaxis.
- Teeth presenting mobility, symptoms, abscess, or tenderness to percussion.
- Radiographic evidence of pulpal pathology.
- Non-restorable teeth.
- Children with severe lack of cooperation (Frankl score 1 or 2).
- Refusal of treatment for aesthetic reasons by the parent or child.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erciyes University, Faculty of Dentistry, Department of Pediatric Dentistry
Kayseri, Kayseri, 38039
About this study
Official title: An 18-Month Split-Mouth Randomized Clinical Trial Comparing the Hall Technique, Silver Diamine Fluoride, and Compomer Restorations for the Management of Caries in Primary Molars in Children Aged 4-8 Years
The goal of this clinical trial is to compare the 18-month clinical success rates of three caries management approaches in primary molars of 60 healthy children aged 4-8 years attending the Department of Pediatric Dentistry at Erciyes University, using a randomized split-mouth design involving 180 treated teeth. The three approaches include the Hall Technique, Silver Diamine Fluoride, and the conventional "drill-and-fill" restorative approach using compomer material. The study will also evaluate pain perception during treatment, child behavior, and treatment acceptability from the perspectives of patients, parents, and dentists. The main questions it aims to answer are:
- Do minimally invasive approaches (Hall Technique and Silver Diamine Fluoride) achieve comparable or superior 18-month clinical success rates compared to the conventional drill-and-fill restorative treatment?
- Do minimally invasive approaches result in lower pain perception, improved child behavior, and greater treatment acceptability compared to the conventional drill-and-fill approach?
Read more
Researchers will compare the three treatment approaches applied to different teeth within the same child to see if minimally invasive methods provide similar or improved clinical outcomes and better patient-centered outcomes over 18 months compared to the conventional approach.
Participants will:
- Contribute three eligible primary molars per child (180 teeth in total).
- Have each tooth randomly assigned to one of the three treatment approaches following a split-mouth design.
- Receive all three interventions within the same participant, with each treatment applied to a different tooth.
- Attend scheduled follow-up visits at 1 month after completion of all interventions, and at 6, 12, and 18 months (final follow-up) for clinical and radiographic evaluation of each treated tooth.
- Provide assessments of pain perception and treatment experience, with additional evaluations completed by parents and treating dentists.
Read the detailed description
This randomized split-mouth clinical trial was designed to evaluate and compare the clinical performance and patient-centered outcomes of three different caries management approaches in primary molars of children.
Dental caries remains one of the most prevalent chronic diseases in childhood. Minimally invasive strategies such as the Hall Technique (HT) and Silver Diamine Fluoride (SDF) have gained increasing attention as alternatives to conventional restorative treatment, particularly in young or anxious pediatric patients. However, comparative clinical data evaluating long-term outcomes and patient-centered measures between these approaches and conventional restorative treatment remain limited.
A total of 60 healthy children aged 4-8 years requiring restorative treatment for at least three primary molars were included. Using a split-mouth design, each child contributed three eligible primary molars (total: 180 teeth). Within each participant, teeth were randomly allocated to receive one of the following interventions:
Hall Technique (placement of a preformed metal crown without caries removal or tooth preparation)
Silver Diamine Fluoride application
Conventional caries removal followed by restoration using compomer material (drill-and-fill approach)
The split-mouth design was selected to minimize inter-individual variability by allowing direct intra-patient comparison of the three treatment modalities.
Clinical and radiographic evaluations were performed at 1 month after completion of all interventions and at 6, 12, and 18 months. The primary outcome measure was 18-month clinical success of each treated tooth. Secondary outcomes included pain perception during treatment, child behavior, and treatment acceptability as assessed by patients, parents, and treating dentists.
This study aims to provide comparative evidence regarding the effectiveness and acceptability of minimally invasive versus conventional restorative approaches in pediatric dentistry.
- Conditions
- Dental Caries
- Being tested
- Hall Technique, Silver diamine Fluoride 38%, Compomer Restoration
- Keywords
- Dental Caries, Primary molars, Pediatric Dentistry, Dental treatment outcomes, Hall Technique, Silver Diamine Fluoride, Split-Mouth Design
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hall TechniqueProcedure or surgery
Also called Preformed Stainless Steel Crown, Stainless Steel Crown, SSC
Placement of a preformed stainless-steel crown (3M ESPE, USA) cemented with glass ionomer luting cement without tooth preparation, local anesthesia, or caries removal.
Silver diamine Fluoride 38%Drug
Also called SDF, 38% SDF
Topical application of a two-step protocol using 38% water-based silver diamine fluoride (step 1) followed by potassium iodide (step 2) (Riva Star Aqua, SDI, Australia) on active cavitated caries lesions extending into dentine. Prior to application, unsupported enamel margins are removed to allow plaque access. The procedure is completed with the application of 22,600 ppm fluoride varnish (Duraphat, GABA, Germany). Applications are repeated at 6- and 12-month follow-up visits.
Compomer RestorationProcedure or surgery
Also called Polyacid-Modified Composite Resin, Dyract
Complete caries removal followed by restoration with compomer material (Dyract, Dentsply, Germany) under local anesthesia as needed.
| Study group | Role | What they receive |
|---|---|---|
| Hall Technique | Experimental | Teeth randomly allocated to this arm were treated using the Hall Technique for the management of carious lesions in primary molars. The intervention consisted of cementation of a preformed stainless-steel crown (3M ESPE, USA) using glass ionomer luting cement, without caries removal, tooth preparation, or local anesthesia. In this split-mouth randomized design, eligible teeth within the same child were allocated to different treatment arms. Clinical evaluations were performed at 1, 6, 12, and 18 months after crown placement. Receives: Procedure: Hall Technique |
| Silver Diamine Fluoride | Experimental | Teeth randomly allocated to this arm were treated with 38% silver diamine fluoride for the management of carious lesions in primary molars. Unsupported enamel was removed and the cavity surface was cleaned using a rotary bristle brush prior to application. A 38% silver diamine fluoride solution with potassium iodide (Riva Star Aqua, SDI, Australia) was applied, followed by 22,600 ppm fluoride varnish (Duraphat, GABA, Germany). In this split-mouth randomized design, eligible teeth within the same child were allocated to different treatment arms. SDF applications were repeated at 6 and 12 months. Clinical evaluations were performed at 1, 6, 12, and 18 months. Receives: Drug: Silver diamine Fluoride 38% |
| Compomer Restoration | Experimental | Teeth randomly allocated to this arm were treated with conventional caries removal and restoration using compomer material for the management of carious lesions in primary molars. Complete caries removal was performed under local anesthesia when clinically indicated, followed by restoration with a compomer material (Dyract, Dentsply, Germany) according to the manufacturer's instructions. In this split-mouth randomized design, eligible teeth within the same child were allocated to different treatment arms. Clinical evaluations were performed at 1, 6, 12, and 18 months. Receives: Procedure: Compomer Restoration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success rate at 18 months
Proportion of treated teeth without clinical or radiographic signs of failure, defined as absence of pain, abscess, fistula, pathological mobility, restoration or crown loss, or caries progression requiring further intervention. Outcomes are assessed through clinical and radiographic examination.
Measured: 18 months
Secondary outcomes (4)
Pain perception during treatment
Child-reported pain perception assessed immediately after treatment using the Visual Analogue Scale (VAS) of Faces. The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates worst possible pain. Higher scores indicate greater pain intensity.
Measured: Periprocedural (Day 1)
Child behavior during treatment
Behavioral response assessed during treatment using the Frankl Behavior Rating Scale, a 4-point ordinal scale ranging from 1 (definitely negative) to 4 (definitely positive). Higher scores indicate more cooperative behavior. The treating dentist assigned the score based on observed cooperation during the procedure.
Measured: Periprocedural (Day 1)
Child treatment acceptability
Child-reported treatment acceptability assessed immediately after treatment using a modified version of the Bell et al. (2010) questionnaire. The instrument consists of five items scored on a 5-point Likert scale ranging from strongly disagree (1) to strongly agree (5). Higher scores indicate greater treatment acceptability.
Measured: Periprocedural (Day 1)
Parental treatment acceptability
Parent-reported treatment acceptability assessed immediately after treatment using a five-item questionnaire scored on a 5-point Likert scale ranging from strongly disagree (1) to strongly agree (5). Higher scores indicate greater treatment acceptability.
Measured: Periprocedural (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start1 Aug 2024
- Primary completion30 Aug 2024
- Study completion9 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by TC Erciyes 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
- Model description
- This study uses a randomized split-mouth design in which each participant contributes three eligible primary molars. Within each child, teeth are randomly assigned to receive one of the three interventions (Hall Technique, Silver Diamine Fluoride, or conventional drill-and-fill restoration). Each participant receives all three treatments on different teeth, allowing intra-individual comparison.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Paula Rueda Manjarres, TC Erciyes University
- Investigators
- Maria Paula Rueda Manjarres, DDS, Principal investigator, Erciyes University, Faculty of Dentistry, Department of Pediatric DentistryHusniye Gumus, DDS, PhD, Study chair, Erciyes University, Faculty of Dentistry, Department of Pediatric Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07447583
- Sponsor's protocol ID
- ERU-MiCROPM-2024-01
- Other IDs
- E-68869993-000-1538193
- Acronym
- MiCRO-PM
- Status last verified
- Feb 2026
- First submitted
- 20 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in publications (text, tables, figures).
Publications
Narbutaite J, Santamaria RM, Innes N, Splieth CH, Maciulskiene V. Comparison of three management approaches for dental caries in primary molars: A two-year randomized clinical trial. J Dent. 2024 Nov;150:105390. doi: 10.1016/j.jdent.2024.105390. Epub 2024 Oct 5.
PubMed 39374732Seifo N, Cassie H, Radford JR, Innes NPT. Silver diamine fluoride for managing carious lesions: an umbrella review. BMC Oral Health. 2019 Jul 12;19(1):145. doi: 10.1186/s12903-019-0830-5.
PubMed 31299955BaniHani A, Santamaria RM, Hu S, Maden M, Albadri S. Minimal intervention dentistry for managing carious lesions into dentine in primary teeth: an umbrella review. Eur Arch Paediatr Dent. 2022 Oct;23(5):667-693. doi: 10.1007/s40368-021-00675-6. Epub 2021 Nov 16.
PubMed 34784027Araujo MP, Innes NP, Bonifacio CC, Hesse D, Olegario IC, Mendes FM, Raggio DP. Atraumatic restorative treatment compared to the Hall Technique for occluso-proximal carious lesions in primary molars; 36-month follow-up of a randomised control trial in a school setting. BMC Oral Health. 2020 Nov 11;20(1):318. doi: 10.1186/s12903-020-01298-x.
PubMed 33176756Santamaria RM, Innes NPT, Machiulskiene V, Schmoeckel J, Alkilzy M, Splieth CH. Alternative Caries Management Options for Primary Molars: 2.5-Year Outcomes of a Randomised Clinical Trial. Caries Res. 2017;51(6):605-614. doi: 10.1159/000477855. Epub 2017 Dec 20.
PubMed 29258064Elamin F, Abdelazeem N, Salah I, Mirghani Y, Wong F. A randomized clinical trial comparing Hall vs conventional technique in placing preformed metal crowns from Sudan. PLoS One. 2019 Jun 3;14(6):e0217740. doi: 10.1371/journal.pone.0217740. eCollection 2019.
PubMed 31158253Hu S, BaniHani A, Nevitt S, Maden M, Santamaria RM, Albadri S. Hall technique for primary teeth: A systematic review and meta-analysis. Jpn Dent Sci Rev. 2022 Nov;58:286-297. doi: 10.1016/j.jdsr.2022.09.003. Epub 2022 Sep 27.
PubMed 36185501Kassebaum NJ, Bernabe E, Dahiya M, Bhandari B, Murray CJ, Marcenes W. Global burden of untreated caries: a systematic review and metaregression. J Dent Res. 2015 May;94(5):650-8. doi: 10.1177/0022034515573272. Epub 2015 Mar 4.
PubMed 25740856
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An 18-Month Split-Mouth Randomized Clinical Trial Comparing the Hall Technique, Silver Diamine Fluoride, and Compomer Restorations for the Management of Caries in Primary Molars in Children Aged 4-8 Years
- ClinicalTrials.gov ID
- NCT07447583
- Acronym / sponsor ID
- MiCRO-PM / ERU-MiCROPM-2024-01
- Conditions
- Dental Caries
- Keywords
- Dental Caries, Primary molars, Pediatric Dentistry, Dental treatment outcomes, Hall Technique, Silver Diamine Fluoride, Split-Mouth Design
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 9 Feb 2026 (actual)
- First posted
- 3 Mar 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.
The goal of this clinical trial is to compare the 18-month clinical success rates of three caries management approaches in primary molars of 60 healthy children aged 4-8 years attending the Department of Pediatric Dentistry at Erciyes University, using a randomized split-mouth design involving 180 treated teeth. The three approaches include the Hall Technique, Silver Diamine Fluoride, and the conventional "drill-and-fill" restorative approach using compomer material. The study will also evaluate pain perception during treatment, child behavior, and treatment acceptability from the perspectives of patients, parents, and dentists. The main questions it aims to answer are:
- Do minimally invasive approaches (Hall Technique and Silver Diamine Fluoride) achieve comparable or superior 18-month clinical success rates compared to the conventional drill-and-fill restorative treatment?
- Do minimally invasive approaches result in lower pain perception, improved child behavior, and greater treatment acceptability compared to the conventional drill-and-fill approach?
Researchers will compare the three treatment approaches applied to different teeth within the same child to see if minimally invasive methods provide similar or improved clinical outcomes and better patient-centered outcomes over 18 months compared to the conventional approach.
Participants will:
- Contribute three eligible primary molars per child (180 teeth in total).
- Have each tooth randomly assigned to one of the three treatment approaches following a split-mouth design.
- Receive all three interventions within the same participant, with each treatment applied to a different tooth.
- Attend scheduled follow-up visits at 1 month after completion of all interventions, and at 6, 12, and 18 months (final follow-up) for clinical and radiographic evaluation of each treated tooth.
- Provide assessments of pain perception and treatment experience, with additional evaluations completed by parents and treating dentists.
Detailed description
This randomized split-mouth clinical trial was designed to evaluate and compare the clinical performance and patient-centered outcomes of three different caries management approaches in primary molars of children.
Dental caries remains one of the most prevalent chronic diseases in childhood. Minimally invasive strategies such as the Hall Technique (HT) and Silver Diamine Fluoride (SDF) have gained increasing attention as alternatives to conventional restorative treatment, particularly in young or anxious pediatric patients. However, comparative clinical data evaluating long-term outcomes and patient-centered measures between these approaches and conventional restorative treatment remain limited.
A total of 60 healthy children aged 4-8 years requiring restorative treatment for at least three primary molars were included. Using a split-mouth design, each child contributed three eligible primary molars (total: 180 teeth). Within each participant, teeth were randomly allocated to receive one of the following interventions:
Hall Technique (placement of a preformed metal crown without caries removal or tooth preparation)
Silver Diamine Fluoride application
Conventional caries removal followed by restoration using compomer material (drill-and-fill approach)
The split-mouth design was selected to minimize inter-individual variability by allowing direct intra-patient comparison of the three treatment modalities.
Clinical and radiographic evaluations were performed at 1 month after completion of all interventions and at 6, 12, and 18 months. The primary outcome measure was 18-month clinical success of each treated tooth. Secondary outcomes included pain perception during treatment, child behavior, and treatment acceptability as assessed by patients, parents, and treating dentists.
This study aims to provide comparative evidence regarding the effectiveness and acceptability of minimally invasive versus conventional restorative approaches in pediatric dentistry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study uses a randomized split-mouth design in which each participant contributes three eligible primary molars. Within each child, teeth are randomly assigned to receive one of the three interventions (Hall Technique, Silver Diamine Fluoride, or conventional drill-and-fill restoration). Each participant receives all three treatments on different teeth, allowing intra-individual comparison.
| Arm | Type | Receives |
|---|---|---|
| Hall Technique | Experimental | Procedure: Hall TechniqueTeeth randomly allocated to this arm were treated using the Hall Technique for the management of carious lesions in primary molars. The intervention consisted of cementation of a preformed stainless-steel crown (3M ESPE, USA) using glass ionomer luting cement, without caries removal, tooth preparation, or local anesthesia. In this split-mouth randomized design, eligible teeth within the same child were allocated to different treatment arms. Clinical evaluations were performed at 1, 6, 12, and 18 months after crown placement. |
| Silver Diamine Fluoride | Experimental | Drug: Silver diamine Fluoride 38%Teeth randomly allocated to this arm were treated with 38% silver diamine fluoride for the management of carious lesions in primary molars. Unsupported enamel was removed and the cavity surface was cleaned using a rotary bristle brush prior to application. A 38% silver diamine fluoride solution with potassium iodide (Riva Star Aqua, SDI, Australia) was applied, followed by 22,600 ppm fluoride varnish (Duraphat, GABA, Germany). In this split-mouth randomized design, eligible teeth within the same child were allocated to different treatment arms. SDF applications were repeated at 6 and 12 months. Clinical evaluations were performed at 1, 6, 12, and 18 months. |
| Compomer Restoration | Experimental | Procedure: Compomer RestorationTeeth randomly allocated to this arm were treated with conventional caries removal and restoration using compomer material for the management of carious lesions in primary molars. Complete caries removal was performed under local anesthesia when clinically indicated, followed by restoration with a compomer material (Dyract, Dentsply, Germany) according to the manufacturer's instructions. In this split-mouth randomized design, eligible teeth within the same child were allocated to different treatment arms. Clinical evaluations were performed at 1, 6, 12, and 18 months. |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged 4 to 8 years.
- Systemically healthy children without any medical or syndromic conditions.
- Frankl Behavior Rating Scale score of 3 (positive) or 4 (definitely positive).
- Presence of at least three unrestored, asymptomatic primary molars with active occluso-proximal dentine caries lesions (ICDAS codes 3, 4, or 5).
- Written informed consent obtained from parents or legal guardians, with willingness to attend follow-up visits.
Key exclusion criteria (7 listed)
- Refusal to provide informed consent or unwillingness to participate.
- Presence of systemic disease or chronic medical conditions requiring special care or antibiotic prophylaxis.
- Teeth presenting mobility, symptoms, abscess, or tenderness to percussion.
- Radiographic evidence of pulpal pathology.
- Non-restorable teeth.
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 |
|---|---|---|
| Hall TechniqueAlso: Preformed Stainless Steel Crown, Stainless Steel Crown, SSCPlacement of a preformed stainless-steel crown (3M ESPE, USA) cemented with glass ionomer luting cement without tooth preparation, local anesthesia, or caries removal. | Procedure or surgery | Hall Technique |
| Silver diamine Fluoride 38%Also: SDF, 38% SDFTopical application of a two-step protocol using 38% water-based silver diamine fluoride (step 1) followed by potassium iodide (step 2) (Riva Star Aqua, SDI, Australia) on active cavitated caries lesions extending into dentine. Prior to application, unsupported enamel margins are removed to allow plaque access. The procedure is completed with the application of 22,600 ppm fluoride varnish (Duraphat, GABA, Germany). Applications are repeated at 6- and 12-month follow-up visits. | Drug | Silver Diamine Fluoride |
| Compomer RestorationAlso: Polyacid-Modified Composite Resin, DyractComplete caries removal followed by restoration with compomer material (Dyract, Dentsply, Germany) under local anesthesia as needed. | Procedure or surgery | Compomer Restoration |
Primary outcome
Clinical success rate at 18 months
Time frame: 18 months
Proportion of treated teeth without clinical or radiographic signs of failure, defined as absence of pain, abscess, fistula, pathological mobility, restoration or crown loss, or caries progression requiring further intervention. Outcomes are assessed through clinical and radiographic examination.
4 secondary outcomes
Pain perception during treatment
Time frame: Periprocedural (Day 1)
Child behavior during treatment
Time frame: Periprocedural (Day 1)
Child treatment acceptability
Time frame: Periprocedural (Day 1)
Parental treatment acceptability
Time frame: Periprocedural (Day 1)
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 3 Mar 2026.
- Background: PubMed 39374732Narbutaite J, Santamaria RM, Innes N, Splieth CH, Maciulskiene V. Comparison of three management approaches for dental caries in primary molars: A two-year randomized clinical trial. J Dent. 2024 Nov;150:105390. doi: 10.1016/j.jdent.2024.105390. Epub 2024 Oct 5.
- Background: PubMed 31299955Seifo N, Cassie H, Radford JR, Innes NPT. Silver diamine fluoride for managing carious lesions: an umbrella review. BMC Oral Health. 2019 Jul 12;19(1):145. doi: 10.1186/s12903-019-0830-5.
- Background: PubMed 34784027BaniHani A, Santamaria RM, Hu S, Maden M, Albadri S. Minimal intervention dentistry for managing carious lesions into dentine in primary teeth: an umbrella review. Eur Arch Paediatr Dent. 2022 Oct;23(5):667-693. doi: 10.1007/s40368-021-00675-6. Epub 2021 Nov 16.
- Background: PubMed 33176756Araujo MP, Innes NP, Bonifacio CC, Hesse D, Olegario IC, Mendes FM, Raggio DP. Atraumatic restorative treatment compared to the Hall Technique for occluso-proximal carious lesions in primary molars; 36-month follow-up of a randomised control trial in a school setting. BMC Oral Health. 2020 Nov 11;20(1):318. doi: 10.1186/s12903-020-01298-x.
- Background: PubMed 29258064Santamaria RM, Innes NPT, Machiulskiene V, Schmoeckel J, Alkilzy M, Splieth CH. Alternative Caries Management Options for Primary Molars: 2.5-Year Outcomes of a Randomised Clinical Trial. Caries Res. 2017;51(6):605-614. doi: 10.1159/000477855. Epub 2017 Dec 20.
- Background: PubMed 31158253Elamin F, Abdelazeem N, Salah I, Mirghani Y, Wong F. A randomized clinical trial comparing Hall vs conventional technique in placing preformed metal crowns from Sudan. PLoS One. 2019 Jun 3;14(6):e0217740. doi: 10.1371/journal.pone.0217740. eCollection 2019.
- Background: PubMed 36185501Hu S, BaniHani A, Nevitt S, Maden M, Santamaria RM, Albadri S. Hall technique for primary teeth: A systematic review and meta-analysis. Jpn Dent Sci Rev. 2022 Nov;58:286-297. doi: 10.1016/j.jdsr.2022.09.003. Epub 2022 Sep 27.
- Background: PubMed 25740856Kassebaum NJ, Bernabe E, Dahiya M, Bhandari B, Murray CJ, Marcenes W. Global burden of untreated caries: a systematic review and metaregression. J Dent Res. 2015 May;94(5):650-8. doi: 10.1177/0022034515573272. Epub 2015 Mar 4.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in publications (text, tables, figures).
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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.
Maria Paula Rueda Manjarres, DDS principal investigator
Erciyes University, Faculty of Dentistry, Department of Pediatric Dentistry
Husniye Gumus, DDS, PhD study chair
Erciyes University, Faculty of Dentistry, Department of Pediatric Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hall Technique, Silver diamine Fluoride 38% and Compomer Restoration in people with Dental Caries, run by TC Erciyes University at 1 site in Turkey (Türkiye).
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: finished, as of the sponsor's last update on 3 Mar 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 Turkey (Türkiye). 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?
Clinical success rate at 18 months (time frame: 18 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 NCT07447583, which also lists 8 linked publications.
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 3 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.