Comparing Minimally Invasive Techniques Used in Treatment of Carious Primary Molars in Children

NCT06592885 | Not Yet Recruiting

• 1 other identifier: HT Vs ART in pedodontics
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

Dental caries is a natural process by which bacteria in the biofilm causes fluctuations in the pH, which leads to enamel erosion and result in visible lesions. If left untreated, caries will progress and result in pain, abscess, and systemic infection, leading to functional and/or psychosocial impairment which is a serious problem Caries is, in fact, the most prevalent childhood disease in the world and is most prominent among low-economic populations. So, the main goal is to minimize Dental caries as much as possible by applying preventive measures to reduce the occurrence and progression of dental caries. In that scope, both Atraumatic Restorative Treatment (ART) and the Hall Technique (HT) were created as part of Minimal Invasive Dentistry (MID) to slow the downward restorative spiral and reduce discomfort during the treatment as neither of which requires the administration of local anesthesia nor the use of rotary instruments. According to a retrospective analysis, utilizing the Hall technique to seal cavities performed much better than using conventional restorations. statistically and clinically during 10 years of follow-up. Since ART is associated with lower levels of anxiety, pain, and discomfort than traditional dentistry procedures, it has become widely employed in pediatric dentistry. Despite having reduced survival rates in multiple-surface restorations, ART is still regarded as a viable, evidence-based choice for treating and preventing caries lesions in primary posterior teeth since it is a quick, inexpensive, and comfortable procedure for the patient.

Conditions

Pediatric Dentistry

Outcome Measures

Primary Outcomes (1)

• Clinical Success, Assessed by clinical examination

  * Standard clinical criteria will be used to determine whether a restoration (ART/HT) was successful or not in terms of having a satisfactory restoration that requires no further intervention and also the absence of any signs or symptoms of pulp damage. * Measuring unit is Binary (Yes/No)

  From enrollment to the end of treatment at 12 months (with follow up at 3-6-9-12 months)

Secondary Outcomes (4)

• Post-operative pain and discomfort

  Measured immediately after placement of SSC or restoration

• Child Behavior

  Measured immediately after placement of SSC or restoration

• Child Anxiety

  Measured immediately after placement of SSC or restoration

• Canine overbite: HT

  Measured in millimeters immediately after placement of pre-fabricated stainless steel crown (SSC)

Study Arms (2)

Hall Technique in treatment of carious primary molars

ACTIVE COMPARATOR

The Hall technique, proposed by Norna Hall in the 1980s, involves the placement of preformed metal crowns on primary molars without any tooth preparation or local anesthesia

Procedure: Hall Technique in treatment of carious primary molars

Atraumatic Restorative Treatment in treatment of carious primary molars

EXPERIMENTAL

ART, which took place in Tanzania during the mid-1980s, is a conservative approach involving the removal of carious lesions using hand instruments, followed by the application of a glass ionomer restoration, promoting the preservation of tooth structure.

Procedure: Atraumatic Restorative Treatment in treatment of carious primary molars

Interventions

Atraumatic Restorative Treatment in treatment of carious primary molars PROCEDURE

ART, which took place in Tanzania during the mid-1980s, is a conservative approach involving the removal of carious lesions using hand instruments, followed by the application of a glass ionomer restoration. This technique aims to be minimally invasive, promoting the preservation of tooth structure. The ART technique, employed in situations where ideal clinical conditions are challenging to achieve, has demonstrated effectiveness as a reliable method for managing cases where conventional treatment methods face resistance from children . However, concerns exist regarding the longevity of ART restorations and the impact of operator skill on outcomes.

Atraumatic Restorative Treatment in treatment of carious primary molars

Hall Technique in treatment of carious primary molars PROCEDURE

The Hall technique, proposed by Norna Hall in the 1980s, involves the placement of preformed metal crowns on primary molars without any tooth preparation or local anesthesia. Advocates of the Hall technique emphasize its simplicity, reduced need for traditional drilling, and high reported success rates in clinical studies. However, concerns have been raised regarding long-term aesthetics and potential psychological impacts due to the visibility of metal crowns.

Hall Technique in treatment of carious primary molars

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age: From 4 to 6 years.
• Caries in primary molars within enamel/dentin with vital pulp.
• Healthy children.
• Cooperative children.

You may not qualify if:

• Presence of signs and symptoms of necrosis.
• Root caries.
• History of Spontaneous pain.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Department of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University.

Cairo, Egypt

Location

Related Publications (1)

• Kaptan A, Korkmaz E. Evaluation of success of stainless steel crowns placed using the hall technique in children with high caries risk: A randomized clinical trial. Niger J Clin Pract. 2021 Mar;24(3):425-434. doi: 10.4103/njcp.njcp_112_20.

  PMID: 33723119 BACKGROUND

Related Links

• Related Info

Study Officials

• Gihan Abou Elneil Professor of Pediatric Dentistry and Dental Public Health, Professor

  Cairo University

  STUDY DIRECTOR

• Ahmed El. Khadem Associate Professor of Pediatric Dentistry, Associate Professor

  Cairo University

  STUDY DIRECTOR

• Dr. Shereen Hassan El-Shamy Lecturer of Pediatric Dentistry

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Mariam Atef Ahmed Dentist, B.D.S., Faculty of Dentistry

CONTACT

1111199543; mariam.wahid@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal invistigator

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: November 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

EG (1)