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

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

Interventions

PROCEDURE

Hall Technique

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

DRUG

Silver diamine Fluoride 38%

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.

PROCEDURE

Compomer Restoration

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

Sponsors & Collaborators

• TC Erciyes University

  lead OTHER

Principal Investigators

• Maria Paula Rueda Manjarres, DDS · Erciyes University, Faculty of Dentistry, Department of Pediatric Dentistry

• Husniye Gumus, DDS, PhD · Erciyes University, Faculty of Dentistry, Department of Pediatric Dentistry

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

4 Years

Max Age

8 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-08-01

Primary Completion

2024-08-30

Completion

2026-02-09

Countries

• Turkey (Türkiye)

Study Locations