Dental CariesNCT02437565
Checking Occlusion During Stainless Steel Crown Placement
A study testing Stainless steel crown and Occlusal Template in people with Dental Caries, run by Riyadh Colleges of Dentistry and Pharmacy at 1 site in Saudi Arabia.
Trial summary
Stainless steel crowns are arguably the most successful posterior restorations in primary teeth and have been so for more than 50 years. Stainless steel crowns offer durability and success rates in excess of 95% making them the restoration of choice for posterior primary teeth in children treated under general… Read more about this study
- Who is it for?
- Ages 4 to 7 years
- Conditions the study is for
- Dental Caries
- What is being tested?
- Stainless steel crown and Occlusal Template
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Aug 2013to Apr 2015
- 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
- No healthy volunteers
- Child
Who may be able to join
- Clinical Diagnosis of Severe Early Childhood Caries
- Have behavioral problems that require management under general anesthesia
- ASA class I
- Deep Dental Caries involving the pulp in all eight primary molars
Who cannot join
- ASA class II or above
- Initial treatment plan cannot be carried out
- Need for extraction or pulpectomy in one or more primary molar
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Checking Occlusion During Stainless Steel Crown Placement in Children Under General Anesthesia - Evaluation of a Novel Technique
Stainless steel crowns are arguably the most successful posterior restorations in primary teeth and have been so for more than 50 years. Stainless steel crowns offer durability and success rates in excess of 95% making them the restoration of choice for posterior primary teeth in children treated under general anesthesia.
Failures of stainless steel crowns placed on primary teeth have been documented using several criteria including marginal adaptation, recurrent caries, abscess formation or root resorption, loss of the crown due to faulty retention and even perforation of the crown . Despite the probability that factors such as root resorption and failure of endodontic treatment could be due to traumatic occlusion, surprisingly little evidence is available in literature on the attempts made to check or evaluate the occlusion of stainless steel crowns placed under general anesthesia The aim of this study was to compare the time taken for placement and the overall success of bilateral multiple stainless crowns placed under general anesthesia using an occlusal index and compare them to crowns placed without such an index, using a randomized control study design
Read the detailed description
A total of 60 patients (32 male and 28 female) aged between 4 and 7 years (Mean age 4.8 years, SD +/- 1.09 years) who met the inclusion criteria were recruited after obtaining informed consent from the parent. No financial incentives were offered for participation in the study. A total of 51 (29 male and 22 female) patients completed the six month follow up requirement (Fig 2).
Evaluation Crowns and the Procedure All patients were evaluated at 24 hours, one week, three months and six months post-operatively. Clinical criteria evaluated included the reporting of pain, discomfort, difficulty in mastication or high points reported by the patient. Tenderness on percussion, presence of premature mobility and clinical evidence of an abscess or fistula were checked by one of the investigators (SCP). Periapical digital radiographs were taken using a digital sensor (Schick Elite, Sirona Dental Inc. Long Island NY. USA) and were evaluated by the same examiner for radiographic evidence of failure. In order to ensure blinding the investigator (SCP) recording the findings was not made aware of which group the patient belonged to. The time taken for each procedure was calculated from the time of placement of the throat pack to the time of removal of the throat pack and was obtained from the intra-operative anesthesiologist notes. If failure of the crown occurred at 3 months, these teeth were excluded from the 6 month evaluation.
Statistical Analyses The parametric values of the control and case groups were compared using the student's t test. The non-parametric values of the control and case groups were compared using the Mann Whitney U test. All tests were conducted at p value of 0.05
- Conditions
- Dental Caries
- Being tested
- Stainless steel crown, Occlusal Template
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stainless steel crownOther
Placement of stainless steel crowns for teeth that have undergone pulpotomy for the treatment of pulpitis induced by severe early childhood caries under general anesthesia
Occlusal TemplateOther
Use of an occlusal template for the placement of stainless steel crowns under general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Placement of stainless steel crown under general anesthesia without the use of an occlusal template Receives: Other: Stainless steel crown |
| Impression | Experimental | Placement of stainless steel crown under general anesthesia with the use of an occlusal template prepared after making an impression of the teeth using a fast setting polyvinyl siloxane material Receives: Other: Stainless steel crown; Other: Occlusal Template |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time taken for the completion of oral rehabilitation
Time taken for the completion of oral rehabilitation under general anesthesia
Measured: Measured at the end of the clinical procedure
Secondary outcomes (3)
Discomfort on Biting
Patient complains of discomfort on biting
Measured: up to 6 months
Radiographic Evidence of Abscess
Presence of abcess on a periapical radiograph
Measured: up to 6 monhts
Dislodgement of crown
Loss of retention of the crown resulting in the dislodgement or complete removal of crown
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2015 (estimated)
- Study startAug 2013
- Primary completionJan 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riyadh Colleges of Dentistry and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Sharat Pani, Riyadh Colleges of Dentistry and Pharmacy
- Investigators
- Sharat C Pani, MDS, Principal investigator, Riyadh Colleges of Dentistry and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02437565
- Sponsor's protocol ID
- FRP/2013/046
- Status last verified
- May 2015
- First submitted
- 24 Apr 2015
- Last updated
- 7 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Checking Occlusion During Stainless Steel Crown Placement in Children Under General Anesthesia - Evaluation of a Novel Technique
- ClinicalTrials.gov ID
- NCT02437565
- Acronym / sponsor ID
- FRP/2013/046
- Conditions
- Dental Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Riyadh Colleges of Dentistry and PharmacyUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 7 May 2015 (estimated)
- 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.
Stainless steel crowns are arguably the most successful posterior restorations in primary teeth and have been so for more than 50 years. Stainless steel crowns offer durability and success rates in excess of 95% making them the restoration of choice for posterior primary teeth in children treated under general anesthesia.
Failures of stainless steel crowns placed on primary teeth have been documented using several criteria including marginal adaptation, recurrent caries, abscess formation or root resorption, loss of the crown due to faulty retention and even perforation of the crown . Despite the probability that factors such as root resorption and failure of endodontic treatment could be due to traumatic occlusion, surprisingly little evidence is available in literature on the attempts made to check or evaluate the occlusion of stainless steel crowns placed under general anesthesia The aim of this study was to compare the time taken for placement and the overall success of bilateral multiple stainless crowns placed under general anesthesia using an occlusal index and compare them to crowns placed without such an index, using a randomized control study design
Detailed description
A total of 60 patients (32 male and 28 female) aged between 4 and 7 years (Mean age 4.8 years, SD +/- 1.09 years) who met the inclusion criteria were recruited after obtaining informed consent from the parent. No financial incentives were offered for participation in the study. A total of 51 (29 male and 22 female) patients completed the six month follow up requirement (Fig 2).
Evaluation Crowns and the Procedure All patients were evaluated at 24 hours, one week, three months and six months post-operatively. Clinical criteria evaluated included the reporting of pain, discomfort, difficulty in mastication or high points reported by the patient. Tenderness on percussion, presence of premature mobility and clinical evidence of an abscess or fistula were checked by one of the investigators (SCP). Periapical digital radiographs were taken using a digital sensor (Schick Elite, Sirona Dental Inc. Long Island NY. USA) and were evaluated by the same examiner for radiographic evidence of failure. In order to ensure blinding the investigator (SCP) recording the findings was not made aware of which group the patient belonged to. The time taken for each procedure was calculated from the time of placement of the throat pack to the time of removal of the throat pack and was obtained from the intra-operative anesthesiologist notes. If failure of the crown occurred at 3 months, these teeth were excluded from the 6 month evaluation.
Statistical Analyses The parametric values of the control and case groups were compared using the student's t test. The non-parametric values of the control and case groups were compared using the Mann Whitney U test. All tests were conducted at p value of 0.05
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Stainless steel crownPlacement of stainless steel crown under general anesthesia without the use of an occlusal template |
| Impression | Experimental | Other: Stainless steel crown, Other: Occlusal TemplatePlacement of stainless steel crown under general anesthesia with the use of an occlusal template prepared after making an impression of the teeth using a fast setting polyvinyl siloxane material |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Clinical Diagnosis of Severe Early Childhood Caries
- Have behavioral problems that require management under general anesthesia
- ASA class I
- Deep Dental Caries involving the pulp in all eight primary molars
Key exclusion criteria (3 listed)
- ASA class II or above
- Initial treatment plan cannot be carried out
- Need for extraction or pulpectomy in one or more primary molar
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 |
|---|---|---|
| Stainless steel crownPlacement of stainless steel crowns for teeth that have undergone pulpotomy for the treatment of pulpitis induced by severe early childhood caries under general anesthesia | Other | Control, Impression |
| Occlusal TemplateUse of an occlusal template for the placement of stainless steel crowns under general anesthesia | Other | Impression |
Primary outcome
Time taken for the completion of oral rehabilitation
Time frame: Measured at the end of the clinical procedure
Time taken for the completion of oral rehabilitation under general anesthesia
3 secondary outcomes
Discomfort on Biting
Time frame: up to 6 months
Radiographic Evidence of Abscess
Time frame: up to 6 monhts
Dislodgement of crown
Time frame: up to 6 months
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 7 May 2015.
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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.
Sharat C Pani, MDS principal investigator
Riyadh Colleges of Dentistry and Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stainless steel crown and Occlusal Template in people with Dental Caries, run by Riyadh Colleges of Dentistry and Pharmacy at 1 site in Saudi Arabia.
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 3 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 7 May 2015. 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 Saudi Arabia. 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?
Time taken for the completion of oral rehabilitation (time frame: Measured at the end of the clinical procedure). 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 7 May 2015.