Traditional vs. Minimally Invasive Decay Treatments in Primary Molars: An 18-month Split-mouth Randomized Study

NCT07447583 | Completed

• 2 other identifiers: ERU-MiCROPM-2024-01E-68869993-000-1538193
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Dental Caries

Keywords

Dental Caries; Primary molars; Pediatric Dentistry; Dental treatment outcomes; Hall Technique; Silver Diamine Fluoride; Split-Mouth Design

Outcome Measures

Primary Outcomes (1)

• 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.

  18 months

Secondary Outcomes (4)

• Pain perception during treatment

  Periprocedural (Day 1)

• Child behavior during treatment

  Periprocedural (Day 1)

• Child treatment acceptability

  Periprocedural (Day 1)

• Parental treatment acceptability

  Periprocedural (Day 1)

Other Outcomes (1)

• Change in occlusal vertical dimension (OVD) after Hall Technique

  Baseline, immediately after treatment, and 1 month after crown placement

Study Arms (3)

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.

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.

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.

Procedure: Compomer Restoration

Interventions

Hall Technique PROCEDURE

Placement of a preformed stainless-steel crown (3M ESPE, USA) cemented with glass ionomer luting cement without tooth preparation, local anesthesia, or caries removal.

Also known as: Preformed Stainless Steel Crown, Stainless Steel Crown, SSC

Hall Technique

Silver diamine Fluoride 38% DRUG

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.

Also known as: SDF, 38% SDF

Silver Diamine Fluoride

Compomer Restoration PROCEDURE

Complete caries removal followed by restoration with compomer material (Dyract, Dentsply, Germany) under local anesthesia as needed.

Also known as: Polyacid-Modified Composite Resin, Dyract

Compomer Restoration

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University, Faculty of Dentistry, Department of Pediatric Dentistry

Kayseri, Kayseri, 38039, Turkey (Türkiye)

Location

Related Publications (8)

• 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.

  PMID: 39374732 BACKGROUND

• Seifo 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.

  PMID: 31299955 BACKGROUND

• BaniHani 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.

  PMID: 34784027 BACKGROUND

• Araujo 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.

  PMID: 33176756 BACKGROUND

• Santamaria 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.

  PMID: 29258064 BACKGROUND

• Elamin 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.

  PMID: 31158253 BACKGROUND

• Hu 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.

  PMID: 36185501 BACKGROUND

• Kassebaum 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.

  PMID: 25740856 BACKGROUND

MeSH Terms

Conditions

Dental Caries

Interventions

Compomers; Dyract

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Composite Resins; Resins, Synthetic; Plastics; Polymers; Macromolecular Substances; Dental Cements; Dental Materials; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Maria Paula Rueda Manjarres, DDS

  Erciyes University, Faculty of Dentistry, Department of Pediatric Dentistry

  PRINCIPAL INVESTIGATOR

• Husniye Gumus, DDS, PhD

  Erciyes University, Faculty of Dentistry, Department of Pediatric Dentistry

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor in Dentistry, Department of Pediatric Dentistry, Faculty of Dentistry, Erciyes University

Model Details: 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.

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: March 3, 2026
• Study Start: August 1, 2024
• Primary Completion: August 30, 2024
• Study Completion: February 9, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 6 months after publication of the primary results and ending 5 years after publication.
• Access Criteria: Access to de-identified individual participant data and supporting documents (study protocol and statistical analysis plan) will be granted to researchers who provide a methodologically sound research proposal. Proposals should include a clear description of the research objectives and planned statistical analyses. Requests will be reviewed by the Principal Investigator and the research team to ensure scientific validity and compliance with ethical standards. Data will be shared after approval of the proposal and execution of a signed data access agreement. Proposals should be submitted to the corresponding author via institutional email.

Locations

TU (1)