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NCT Number: NCT06592885

Comparing Minimally Invasive Techniques Used In Treatment Of Carious Primary Molars In Children

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.

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Key information

Conditions

Pediatric Dentistry

Age range

4 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Cairo, Egypt

Location contact

Faculty of Dentistry Cairo University Faculty of Dentistry Cairo University

CONTACT

[email protected]

(+202) 23634965

About this study

One of the most prevalent childhood diseases, dental caries, affects up to 90% of children globally, especially those from the underprivileged group.

WHO estimates that Egypt has a 60% prevalence of dental caries. Early childhood caries has a negative effect on a child's oral health-related quality of life. Both the family and the child are directly affected.

The ideal treatment of carious lesions has been the subject of recent revolutions. Traditional restorative methods, which focused on completely removing carious tooth tissue and then placing a restoration have been replaced by more biological and minimally invasive methods that concentrate on controlling biofilms and disrupting the cariogenic biofilm environment to stop caries.

The Hall Technique (HT) supports this theory. Without any dental preparation or caries removal, a preformed metal crown (PMC) is simply fixed to the carious tooth using glass ionomer cement (GIC). The cariogenic biofilm beneath the cap is sealed.

The Hall technique of stainless- steel crown placement has proved to be a viable restorative option for carious primary molars resulting in its successful exfoliation.

Management techniques would include atraumatic restorative treatment as well as those in which dentine carious tissue is selectively removed to soft or firm dentine in a single session (ART).

ART has been widely used in pediatric dentistry because it is linked with lower levels of anxiety, pain, and discomfort, as well as better acceptance by children, compared to conventional treatment.

ART uses only hand instruments to remove carious tissue and prepare the cavity. Additional extended clinical investigations are required to assess the effectiveness of these methods in addressing carious lesions on diverse tooth surfaces and various dentin layers and to provide evidence supporting the integration of these techniques into standard practice.

Since there is a need for further research, with larger sample sizes and extended follow-up durations in Egypt, to assess the effectiveness of these methods for treating carious primary teeth, this study will be conducted.

This research aims to compare the success of the Hall Technique to the Atraumatic Restorative treatment in the management of carious primary molars in children.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Clinical Success, Assessed by clinical examination

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

    • 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)

Secondary outcomes

  1. Post-operative pain and discomfort

    Time frame: Measured immediately after placement of SSC or restoration

    Immediately after the treatment, any pain and discomfort experienced by the child will be recorded using the Face Pain Scale - revised (FPS-R), which has six numbered faces from 0 to10. Each child will be asked to mark the face that reflects her or his experienced pain during the treatment. There is no pain visible on the first face [indicating the face on the far left]. As you move from left to right, the faces get progressively more painful until you reach the last, which is incredibly painful [indicating the face on the far right]. The (FPS-R) faces will be scored as 0-2-4-6-8-10.

  2. Child Behavior

    Time frame: Measured immediately after placement of SSC or restoration

    Venham Anxiety Rating Scale is a reliable system for rating behavior of children in the dental setting, a child's fear and lack of cooperation are assessed using five behaviorally defined categories, ranging from zero to five (Six-point scales 0-1- 2-3-4-5), which are included in each measure; higher values denote greater anxiety or an uncooperative manner.

  3. Child Anxiety

    Time frame: Measured immediately after placement of SSC or restoration

    Venham behavior rating scale is a reliable system for rating the behavior of children in the dental setting.a child's fear and lack of cooperation are assessed using five behaviorally defined categories, ranging from zero to five (Six-point scales 0-1- 2-3-4-5), which are included in each measure; higher values denote greater anxiety or an uncooperative manner.

  4. Canine overbite: HT

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

    • The canine overbite will be calculated in millimeters before the preparation by measuring the distance between the incisal points of the maxillary canine on the same side of the mouth to the gingival zenith of the mandibular canine using a Boley's Gauge.
    • If checking the same side was not possible (e.g., loss of canine) the distance between canines on the other side will be measured.
    • These prefabricated SSCs will be pre-trimmed to the optimum length, belled, and pre-crimped at the cervical margin.
    • The SSC will be loaded with glass ionomer luting cement and partially fitted on the tooth using a finger. The patient will be asked to bite on a cotton roll and the SSC will be fully seated.
    • Excess cement will be removed; Post-treatment overbite (immediately after the treatment) will be recorded.
    • Changes in the canine overbite will be determined by subtracting the follow-up canine overbite from the baseline (pretreatment).

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

1111199543 ext. +20

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Evaluation Of Success Of Hall Technique Versus Atraumatic Restorative Treatment In The Management Of Carious Primary Molars: A Randomized Clinical Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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