Comparative Evaluation of Effectiveness of Hall Technique and Resin Modified Glass Ionomer Cement in Controlling Occlusoproximal Caries in Primary Molars in Children

Dental Caries Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04355000
• Other study ID #: Saurabh@Pedo#PGIDS
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: November 2020

Study information

• Verified date: April 2020
• Source: Postgraduate Institute of Dental Sciences Rohtak
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: November 2020
• Est. primary completion date: November 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 8 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Caries

Intervention

Procedure:
• Hall technique
SS Crown will be cemented on primary carious molar which satisfy the inclusion criterion without any carious removal, without any tooth preperation, without any local anaesthesia.
• RMGIC restoration
Complete removal of caries and filling will be done with RMGIC material

Locations

Country	Name	City	State
India	Post Graduate Institute of Dental Sciences	Rohtak	Haryana

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Dental Sciences Rohtak

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical success	Clinical success will be assessed by absence of clinical signs and symptoms	Baseline to 12 months
Secondary	Radiographic success	Absence of periapical alterations (radiolucency at furcal or periapical region).	Baseline to 12 months