Clinical trial NCT04355000: Comparative Evaluation of Effectiveness of Hall Technique and Resin Modified Glass Ionomer Cement in Controlling Occlusoproximal Caries in Primary Molars in Children
Official title: Comparative Evaluation of Effectiveness of Hall Technique and Resin Modified Glass Ionomer Cement in Controlling Occlusoproximal Caries in Dentin of Primary Molars in Children : A Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Caries
Keywords: RMGIC, Hall Technique, Dental caries in primary molars.
Lead sponsor: Postgraduate Institute of Dental Sciences Rohtak
Sponsor class: OTHER
First posted: 2020-04-21
Enrollment: 90
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: •To investigate clinical and radiographic outcomes of Hall Technique and conventional restorative care using RMGIC in occulusoproximal carious lesions of primary molars in children.

Detailed description: Dental caries is one of the most common preventable diseases which is recognized as the primary cause of oral pain and tooth loss. WHO claimed that poor oral health may have a profound effect on general health as well as quality of life. Dental caries is not an infectious disease that needs to be "cured" by removing bacteria or, even less so, a particular bacterial species. Instead, dental caries can be managed behaviorally by controlling its causative factors-namely, the supply of fermentable carbohydrates and the presence and maturation of bacterial dental biofilms.

Resin modified Glass ionomer cement (RMGIC) has been used as a material for placement of dental restorations and is known to release fluoride which can help to remineralize carious lesion. RMGIC has excellent compressive and tensile strength compared to water based material, very less sensitive to moisture during initial setting time, excellent bonding with tooth, long working time with rapid set and early strength, have lower modulus of elasticity, twice flexible compared to water based glass ionomers. Chisini et al conducted a systematic review and showed 93.6% success rate of RMGIC, 91.2% for compomer, 79.3% for composite resin in primary teeth restoration.

The Hall Technique (HT) is a method for restoring children's carious primary molars uses a preformed stainless steel crown (SSC) cemented with no caries removal, tooth preparation, or local anaesthesia. Schwendicke F reported that HT showed high cost-effectiveness, dominating conventional restoration mainly because HT is clinically more successful and result in significantly fewer retreatments. The Hall Technique has been shown to be a durable (being likely to last the lifespan of the primary molar) and economical management option for primary molars with carious lesions, which in addition offers the benefit of full coronal coverage, reducing the risk of future carious lesion development.

The patients will be randomly allocated into two groups:

Group 1 - 45 Teeth will be treated using Hall Technique. Group 2 - 45 Teeth will be treated using resin modified glass ionomer cement(Vitremer).

Eligibility criteria: Inclusion Criteria:

* Children aged between 4 to 8 years.
* Occlusoproximal caries into dentin affecting one or more than one surface,
* Crown is restorable.
* Absence of clinical signs and symptoms
* More than half root remaining.
* No complicating medical history
* Child able to co-operate.
* Parent and child have consented.
* Patient ready for radiographs.

Exclusion Criteria:

* Signs or symptoms of irreversible pulpitis, or dental abscess/fistula.
* Radiographic signs of pulpal involvement, or periradicular pathology.
* Where there is no cooperation as there is a risk of crown aspiration or swallowing.
* Patients at risk of infective endocarditis; immunocompromised children.
* Parents/carers do not give written consent for treatment.

Primary outcomes:
measure: Clinical success
timeFrame: Baseline to 12 months
Secondary outcomes:
measure: Radiographic success
timeFrame: Baseline to 12 months
Other outcomes:
Locations:
city: Rohtak
country: India
facility: Post Graduate Institute of Dental Sciences
state: Haryana
Study officials:
References: