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

Primary Purpose

Dental Caries

Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Hall technique
RMGIC restoration
Sponsored by
Postgraduate Institute of Dental Sciences Rohtak
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring RMGIC, Hall Technique, Dental caries in primary molars.

Eligibility Criteria

4 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Post Graduate Institute of Dental Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Hall Technique

RMGIC restoration

Arm Description

In 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.

In RMGIC(Vitremer) filling, carious lesion will be completely removed from primary molars using air rotor and local anaesthesia according to need and filled with vitremer rmgic material.

Outcomes

Primary Outcome Measures

Clinical success
Clinical success will be assessed by absence of clinical signs and symptoms

Secondary Outcome Measures

Radiographic success
Absence of periapical alterations (radiolucency at furcal or periapical region).

Full Information

First Posted
April 17, 2020
Last Updated
May 13, 2020
Sponsor
Postgraduate Institute of Dental Sciences Rohtak
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1. Study Identification

Unique Protocol Identification Number
NCT04355000
Brief Title
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

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
November 2020 (Anticipated)
Study Completion Date
November 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Postgraduate Institute of Dental Sciences Rohtak

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
RMGIC, Hall Technique, Dental caries in primary molars.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hall Technique
Arm Type
Active Comparator
Arm Description
In 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.
Arm Title
RMGIC restoration
Arm Type
Active Comparator
Arm Description
In RMGIC(Vitremer) filling, carious lesion will be completely removed from primary molars using air rotor and local anaesthesia according to need and filled with vitremer rmgic material.
Intervention Type
Procedure
Intervention Name(s)
Hall technique
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
RMGIC restoration
Intervention Description
Complete removal of caries and filling will be done with RMGIC material
Primary Outcome Measure Information:
Title
Clinical success
Description
Clinical success will be assessed by absence of clinical signs and symptoms
Time Frame
Baseline to 12 months
Secondary Outcome Measure Information:
Title
Radiographic success
Description
Absence of periapical alterations (radiolucency at furcal or periapical region).
Time Frame
Baseline to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Post Graduate Institute of Dental Sciences
City
Rohtak
State/Province
Haryana
ZIP/Postal Code
124001
Country
India

12. IPD Sharing Statement

Learn more about this trial

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

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