Caries, DentalMODNCT03552835
Management of Occlusal Dentinal Caries in Deciduous Molars
A study testing no caries removal, partial caries removal upto soft dentin and partial caries removal upto firm dentin in people with Caries, Dental, run by Sneha D. Suwarnkar at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries, Dental
- What is being tested?
- no caries removal, partial caries removal upto soft dentin and partial caries removal upto firm dentin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 30 Oct 2017to 10 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Management of Occlusal Dentinal Caries in Deciduous Molars- A Clinical and Radiographic Evaluation of Three Approaches
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.
Read the 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.
- Conditions
- Caries, Dental
- Being tested
- no caries removal, partial caries removal upto soft dentin, partial caries removal upto firm dentin
- Keywords
- no caries removal, partial caries removal upto soft dentin, partial caries removal upto firm dentin
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no caries removalProcedure or surgery
occlusal caries were treated with no caries removal and placement of stainless steel crown
partial caries removal upto soft dentinProcedure or surgery
occlusal caries were treated by partial caries removal upto soft dentin followed by Glass Ionomer Cement placement as a base and composite restoration
partial caries removal upto firm dentinProcedure or surgery
occlusal caries were treated by partial caries removal upto firm dentin followed by Glass Ionomer Cement placement as a base and composite restoration
| Study group | Role | What they receive |
|---|---|---|
| no caries removal | Experimental | mandibular occlusal caries were treated with placement of stainless steel crown with no caries removal Receives: Procedure: no caries removal |
| partial caries removal upto soft dentin | Experimental | mandibular occlusal caries were treated by partial caries removal upto soft dentin Receives: Procedure: partial caries removal upto soft dentin |
| partial caries removal upto firm dentin | Experimental | mandibular occlusal caries were treated by partial caries removal upto firm dentin Receives: Procedure: partial caries removal upto firm dentin |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between caries activity and efficacy of three groups
to check for caries activity and efficacy of three groups i.e. no caries removal, partial caries removal upto soft dentin and partial caries removal upto firm dentin
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2018
- Study start30 Oct 2017
- Primary completion30 Nov 2018
- Study completion10 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries, DentalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sneha D. Suwarnkar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sneha D. Suwarnkar, Saraswati-Dhanwantari Dental College & Hospital
- Investigators
- Sneha D Suwarnkar, MDS, Principal investigator, Saraswati Dhanwantari Dental College and Hospital, Parbhani
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03552835
- Sponsor's protocol ID
- SarswatiDhanwantari
- Acronym
- MOD
- Status last verified
- Jan 2019
- First submitted
- 30 May 2018
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Occlusal Dentinal Caries in Deciduous Molars- A Clinical and Radiographic Evaluation of Three Approaches
- ClinicalTrials.gov ID
- NCT03552835
- Acronym / sponsor ID
- MOD / SarswatiDhanwantari
- Conditions
- Caries, Dental
- Keywords
- no caries removal, partial caries removal upto soft dentin, partial caries removal upto firm dentin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sneha D. SuwarnkarUniversity, hospital or other
- Study start
- 30 Oct 2017 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 10 Dec 2018 (actual)
- First posted
- 12 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| no caries removal | Experimental | Procedure: no caries removalmandibular occlusal caries were treated with placement of stainless steel crown with no caries removal |
| partial caries removal upto soft dentin | Experimental | Procedure: partial caries removal upto soft dentinmandibular occlusal caries were treated by partial caries removal upto soft dentin |
| partial caries removal upto firm dentin | Experimental | Procedure: partial caries removal upto firm dentinmandibular occlusal caries were treated by partial caries removal upto firm dentin |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no caries removalocclusal caries were treated with no caries removal and placement of stainless steel crown | Procedure or surgery | no caries removal |
| partial caries removal upto soft dentinocclusal caries were treated by partial caries removal upto soft dentin followed by Glass Ionomer Cement placement as a base and composite restoration | Procedure or surgery | partial caries removal upto soft dentin |
| partial caries removal upto firm dentinocclusal caries were treated by partial caries removal upto firm dentin followed by Glass Ionomer Cement placement as a base and composite restoration | Procedure or surgery | partial caries removal upto firm dentin |
Primary outcome
correlation between caries activity and efficacy of three groups
Time frame: 12 months
to check for caries activity and efficacy of three groups i.e. no caries removal, partial caries removal upto soft dentin and partial caries removal upto firm dentin
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sneha D Suwarnkar, MDS principal investigator
Saraswati Dhanwantari Dental College and Hospital, Parbhani
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing no caries removal, partial caries removal upto soft dentin and partial caries removal upto firm dentin in people with Caries, Dental, run by Sneha D. Suwarnkar at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation between caries activity and efficacy of three groups (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2019.