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.

Timeline

Start

2024-08-01

Primary completion

2024-08-30

Completion

2026-02-09

Publications

• Background 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

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