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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-6
SponsorCairo University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: From 4 to 6 years.

Caries in primary molars within enamel/dentin with vital pulp.

Healthy children.

Cooperative children.

Disqualifiers

Presence of signs and symptoms of necrosis.

Root caries.

History of Spontaneous pain.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Atraumatic Restorative Treatment in treatment of carious primary molars

    Procedure/Surgery

    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/Surgery

    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.

Treatment groups

68 Participants
are divided into 2 treatment groups
Group A: Hall Technique in treatment of carious primary molarsActive comparator 1 intervention
Group B: Atraumatic Restorative Treatment in treatment of carious primary molarsExperimental treatment 1 intervention

Trial outcomes

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)

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

Secondary outcomes

1

Post-operative pain and discomfort

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.

Time frame
Measured immediately after placement of SSC or restoration
2

Child Behavior

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.

Time frame
Measured immediately after placement of SSC or restoration
3

Child Anxiety

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.

Time frame
Measured immediately after placement of SSC or restoration
4

Canine overbite: HT

1. 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. 2. If checking the same side was not possible (e.g., loss of canine) the distance between canines on the other side will be measured. 3. These prefabricated SSCs will be pre-trimmed to the optimum length, belled, and pre-crimped at the cervical margin. 4. 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. 5. Excess cement will be removed; Post-treatment overbite (immediately after the treatment) will be recorded. 6. Changes in the canine overbite will be determined by subtracting the follow-up canine overbite from the baseline (pretreatment).

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

Other outcomes

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