Clinical trial NCT03552835: Management of Occlusal Dentinal Caries in Deciduous Molars
Official title: Management of Occlusal Dentinal Caries in Deciduous Molars- A Clinical and Radiographic Evaluation of Three Approaches
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caries, Dental
Keywords: no caries removal
partial caries removal upto soft dentin
partial caries removal upto firm dentin
Lead sponsor: Saraswati-Dhanwantari Dental College & Hospital
Sponsor class: OTHER
First posted: 2018-06-12
Enrollment: 60
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: occlusal dentinal caries were managed by either partial caries removal upto soft dentin or partial caries removal upto firm dentin or no caries removal and were compared
Primary purpose: TREATMENT

Brief summary: This study evaluated and compared the efficacy of no caries removal and sealing with a well-adapted and crimped stainless steel crown verses selective caries removal upto soft dentin and upto firm dentin in healing and/or preventing progression of moderate to deep occlusal dentinal caries.

Detailed description: Dental caries is a complex multifactorial disease and is one of the most prevalent diseases throughout history. It can cost a lot of money to treat and causes infection, pain and the loss of teeth. Choices for managing a carious lesion cover a spectrum of options-from complete surgical excision, where no part of the visible carious tissue is left in the tooth before a restoration is placed, to the opposite extreme, where none of the carious tissue is removed and noninvasive methods are used to prevent progression of the lesion. Thus, this study compared efficacy of no caries removal and sealing the entire lesion verses partial selective caries removal to soft and to firm dentin in healing and/or preventing progression of moderate to deep occlusal dentinal caries in previously unrestored teeth by clinical and radiographic analysis in 4-7 year old children.

Eligibility criteria: Inclusion Criteria:

* Children in the age group of 4 - 7 years
* Previously untreated first and second mandibular deciduous molars with moderate to deep occlusal caries i.e. caries involving middle 1/3rd to pulpal 1/3rd of dentin
* No root resorption or physiologic resorption not exceeding 2/3rd of the root length
* Children having positive and definitely positive behavior

Exclusion Criteria:

* Children with special health care needs
* Children with dental crowding limiting the child's ability to maintain oral hygiene
* Teeth with clinical and/or radiological signs or symptoms of non- vitality
* Teeth with clinical and radiological signs or symptoms of irreversible pulpitis or dental abscess (Pain, mobility, tenderness to percussion, draining sinus, pulp polyp, furcal or periapical radiolucency, root resorption)
* Mobility of the tooth
* Pathologic root resorption
* Physiologic root resorption exceeding 2/3rd of root length in preoperative x-ray

Primary outcomes:
measure: correlation between caries activity and efficacy of three groups
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Parbhani
country: India
facility: Dr Sneha D Suwarnkar
state: Maharashtra
Study officials:
affiliation: Saraswati Dhanwantari Dental College and Hospital, Parbhani
name: Sneha D Suwarnkar, MDS
role: PRINCIPAL_INVESTIGATOR
References: