An interventional study of Hall Technique and Modified Hall Technique in Dental Caries in Children, Tooth Diseases and Tooth Demineralization, sponsored by Ankara Yildirim Beyazıt University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 3 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-06.
Sponsored by Ankara Yildirim Beyazıt University · Not applicable, Interventional, and Treatment
The purpose of this randomized clinical trial is to compare the clinical/radiographic success of Hall technique and modified Hall technique in the treatment of primary molars with deep dentine carious lesions in children (3-12-year-old). The secondary aim is to examine the effect of marginal ridge breakdown level on treatment success.
Untreated caries in deciduous teeth affect 532 million children worldwide. According to the Turkey Oral and Dental Health Profile study conducted in 2018, the prevalence of untreated caries in 5-year-old children is 64.4%. The traditional treatment of dentine caries is to restore the teeth after removal of the carious tissue. There is increasing evidence for minimally invasive interventions as an alternative to this traditional operative/restorative treatment.
One of the minimally invasive treatment approaches applied in children is the Hall Technique. Local anesthesia and tooth preparation are not required in this technique, and decayed primary molars are covered with stainless steel crowns without removing any carious tissue. The Hall technique has advantages such as preventing aerosol formation, shortening the treatment time, increasing patient cooperation, and reducing the need for general anesthesia and sedation in noncompliant patients. Its popularity has also increased during the Covid-19 process.
The success of the Hall technique in primary teeth with deep caries has been investigated in a limited number of clinical studies, and it has been observed that the technique has lower success rates in teeth with deep caries than in teeth with shallow/medium depth caries. To answer the question of whether modifying the Hall technique (removing the necrotic carious dentin layer manually with excavators before placing a stainless-steel crown) in deeply carious primary molars will increase the success of the original Hall technique (placing stainless steel crown without any intervention to the carious lesion), a randomized study was designed.
268 healthy children between the ages of 3-12 will be recruited from Ankara Yıldırım Beyazıt University Faculty of Dentistry, Department of Pediatric Dentistry outpatient clinic. Participants who met the inclusion criteria and agreed to participate will be randomly allocated to Group 1 (Modified Hall Technique) or Group 2 (Hall Technique).
The allocation of patients in each group will be carried out by a random list. The sequence will be generated by a computerized random number generator. Enclosed assignments in sequentially numbered, opaque, sealed envelopes will be used as allocation concealment mechanism. Group allocation will be performed by an independent researcher, not involved in the study.
Clinical and radiographic success of treatments will be determined at follow-up appointments at 3rd, 6th and 12th months by one blinded examiner. In follow-up appointments; treatments will be recorded as "successful" (restoration appears satisfactory, no intervention required/ no clinical signs or symptoms of pulpal pathology/ no pathology visible on radiographs/ tooth exfoliated), "minor failure" (crown perforation/ new caries (around margins)/ restoration loss; tooth restorable/ reversible pulpitis treated without requiring pulpotomy or extraction) or "major failure" (irreversible pulpitis or dental abscess requiring pulpotomy or extraction/ inter-radicular radiolucency/ restoration loss; tooth unrestorable/ internal root resorption).
27 studies on the registry are indexed under Tooth Demineralization; 9 are open to participants now.
This study's enrollment of 268 is above the median of 40 across 27 interventional studies indexed under Tooth Demineralization.
Browse Tooth Demineralization studies →Ankara Yildirim Beyazıt University is the lead sponsor of 241 studies on the registry; 54 are open to participants now.
Compared within Tooth Demineralization, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Tooth Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Tooth inclusion criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A preformed metal crown will be cemented on the carious primary molar tooth without any tooth preparation and local anesthesia.
Procedure: Hall Technique
In the Modified Hall technique only infected soft dentin tissue will be removed with hand instruments and a preformed metal crown will be placed with Hall technique.
Procedure: Modified Hall Technique
* Only food scraps or debris will be removed from the caries cavity. * The smallest crown size will be selected that covers all cusps and approaches the contact points with a slight "springback" feel. * If the contact points are tight, orthodontic elastic separators will be placed through the contacts and the SSC will be placed at the second appointment 3-5 days later. * The SSC will be loaded with glass ionomer luting cement and placed evenly on the tooth. * The child will be asked to bite firmly until the crown is pushed down over the tooth. * If the child is unable or unwilling to bite down on the SSC, finger pressure will be used to seat the crown * The child will continue to bite on a cotton roll until the cement hardens * Excess glass ionomer cement will be removed from the crown margins with hand instruments and dental floss.
* Food scraps or debris will be cleaned from the caries cavity and infected soft carious dentin tissue will be excavated with hand instruments. * The smallest crown size will be selected that covers all cusps and approaches the contact points with a slight "springback" feel. * If the contact points are tight, orthodontic elastic separators will be placed through the contacts and the SSC will be placed at the second appointment 3-5 days later. * The SSC will be loaded with glass ionomer luting cement and placed evenly on the tooth. * The child will be asked to bite firmly until the crown is pushed down over the tooth. * If the child is unable or unwilling to bite down on the SSC, finger pressure will be used to seat the crown * The child will continue to bite on a cotton roll until the cement hardens * Excess glass ionomer cement will be removed from the crown margins with hand instruments and dental floss.
Clinical and radiographic success of the treatments
The clinical evaluation will be performed by one blinded examiner with the criteria as proposed by Innes et al. (2007). Outcome criteria for the clinical and radiographic assessment of restorations and teeth will be as follows: Treatments will be considered as "successful" if the restoration appears satisfactory (no intervention required), no clinical signs or symptoms of pulpal pathology, no pathology visible on radiographs or tooth exfoliated The treatments will be classified as "minor failure" if there is a crown perforation, new caries around margins, restoration loss (tooth restorable) and/or reversible pulpitis treated without requiring pulpotomy or extraction. The treatments will be classified as "major failure" if there is irreversible pulpitis or dental abscess requiring pulpotomy or extraction, inter-radicular radiolucency, restoration loss (tooth unrestorable) and/or internal root resorption (Innes et al., 2007).
Time frame: Change from baseline up to 3, 6 and 12 months
The effect of the amount of marginal ridge fracture on treatment success
The extent of marginal ridge breakdown will be determined by the ratio of the amount of fractured marginal ridge to the total marginal ridge of the tooth and will be scored in 4 groups (\<25%, 25-50%, 50-75%, \>75%) (Cho et al.,2018).
Time frame: Change from baseline up to 3, 6 and 12 months
Plan to share: No
Ran from Feb 2022 to primary completion in Sep 2023, 19 months.
Of 16 interventional studies with no phase under Tooth Demineralization, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 21. This study's 19 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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