Fractured ToothNCT04685161
Comparison of Surgical Extrusion vs. Fibre Post Restoration for Crown-root Fractured Maxillary Incisors.
A study testing Surgical extrusion and Fibre post in people with Fractured Tooth, run by Tamil Nadu Dr.M.G.R.Medical University at 1 site in India.
Trial summary
A total of 124 samples was calculated to be sufficient with G*power software ver 3.1.9.2 with effect size of 0.4 alpha probability error and power 0.95.With drop out estimate of 10% the final sample size decided was 140 samples. Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Fractured Tooth
- What is being tested?
- Surgical extrusion and Fibre post
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteIndia
- Study dates
- 15 Jan 2021to May 2023
- 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 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- patients with complicated crown root fracture
- patients willing for recall
- Good oral hygiene
Who cannot join
- patients not willing for recall
- Patients health rendering root canal treatment
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Csi College of Dental Sciences and Research
Madurai, Tamil Nadu, 625001
Rahul B Dr, MDS, 7598326175, raghulram22@gmail.com
About this study
Official title: Comparison of Surgical Extrusion vs Fibre Post Restoration for Crown-root Fractured Maxillary Incisors. Randomized Clinical Trial
A total of 124 samples was calculated to be sufficient with G*power software ver 3.1.9.2 with effect size of 0.4 alpha probability error and power 0.95.With drop out estimate of 10% the final sample size decided was 140 samples. Patients reporting with complicated(pulp exposed or pulpally involved) horizontal crown root fracture with loss of crown structure in maxillary incisors and radiograph evidence of supra alveolar tooth structure are recruited for study. Informed consent from the patients or guardian as appropriate is obtained as suitable prior to treatment delivery. Exclusion criteria were:patients not willing for recall visits, root with evidence of cervical resorption or roor canal filling, open apices, patient with systemic ailments rendering root canal treatment, compromised periodontal health, vertical or horizontal root fracture. Pulpal condition of tooth was assessed using cold sensibility test(Neosnow, orikam health care Ltd, India.) amd confirmed upon access opening with teeth showing evidence of pulpal bleeding wad categorized as irreversible pulpitis and teeth with no evidence of pulpal bleeding categorized as necrotic pulp.
Read the detailed description
Patients are randomly alloted to treatment groups. Group I-Root canal treatment followed by surgical extrusion of teeth till about 40%supra gingival crown structure is visible clinically.
Group II-Root canal treatment followed by glass fibre post placement (Reforpost, Angelus, Brazil) and composite (charisma smart, Germany) core build up with porcelain fused metal crown.
Post treatment visits are scheduled 6,12,18 months, scheduled visits were planned as close as possible to the study protocol, but for the purpose of data collection, any recall visit occuring within plus or minus 10% of the advocated time was considered aa occuring at that time. Recall visit check up included clinical examination for mobility, periapical tenderness, gingival pocket depth estimation,bleeding on probing and radiographic examination. Patients are asked to report immediately of any unforeseen circumstances arises in the restored teeth.
- Conditions
- Fractured Tooth
- Being tested
- Surgical extrusion, Fibre post
- Medical subject headings
- Tooth Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical extrusionProcedure or surgery
Invasive treatment option for fractured tooth
Fibre postDevice
Easy approach for treatment
| Study group | Role | What they receive |
|---|---|---|
| Surgical extrusion | Experimental | Novel and alternative treatment option for horizontal crown root fractured maxillary incisors Receives: Procedure: Surgical extrusion |
| Fibre post | Active comparator | Treatment modality normally used for crown-root fractured tooth Receives: Device: Fibre post |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic healing of teeth is measured
Periapical index score(PAI) is used for assessment
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start15 Jan 2021
- Primary completionMay 2022 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fractured ToothStudies 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
- Model description
- 2 groups are used One using fibre post placement And the other using surgical extrusion
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tamil Nadu Dr.M.G.R.Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rahul Baskar, Tamil Nadu Dr.M.G.R.Medical University
- Investigators
- ANAND SHERWOOD, MDS, Study director, TNMGRMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04685161
- Sponsor's protocol ID
- CSICOLLEGE
- Status last verified
- Mar 2021
- First submitted
- 16 Dec 2020
- Last updated
- 30 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Surgical Extrusion vs Fibre Post Restoration for Crown-root Fractured Maxillary Incisors. Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04685161
- Acronym / sponsor ID
- CSICOLLEGE
- Conditions
- Fractured Tooth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Tamil Nadu Dr.M.G.R.Medical UniversityUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- May 2022 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 28 Dec 2020 (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.
A total of 124 samples was calculated to be sufficient with G*power software ver 3.1.9.2 with effect size of 0.4 alpha probability error and power 0.95.With drop out estimate of 10% the final sample size decided was 140 samples. Patients reporting with complicated(pulp exposed or pulpally involved) horizontal crown root fracture with loss of crown structure in maxillary incisors and radiograph evidence of supra alveolar tooth structure are recruited for study. Informed consent from the patients or guardian as appropriate is obtained as suitable prior to treatment delivery. Exclusion criteria were:patients not willing for recall visits, root with evidence of cervical resorption or roor canal filling, open apices, patient with systemic ailments rendering root canal treatment, compromised periodontal health, vertical or horizontal root fracture. Pulpal condition of tooth was assessed using cold sensibility test(Neosnow, orikam health care Ltd, India.) amd confirmed upon access opening with teeth showing evidence of pulpal bleeding wad categorized as irreversible pulpitis and teeth with no evidence of pulpal bleeding categorized as necrotic pulp.
Detailed description
Patients are randomly alloted to treatment groups. Group I-Root canal treatment followed by surgical extrusion of teeth till about 40%supra gingival crown structure is visible clinically.
Group II-Root canal treatment followed by glass fibre post placement (Reforpost, Angelus, Brazil) and composite (charisma smart, Germany) core build up with porcelain fused metal crown.
Post treatment visits are scheduled 6,12,18 months, scheduled visits were planned as close as possible to the study protocol, but for the purpose of data collection, any recall visit occuring within plus or minus 10% of the advocated time was considered aa occuring at that time. Recall visit check up included clinical examination for mobility, periapical tenderness, gingival pocket depth estimation,bleeding on probing and radiographic examination. Patients are asked to report immediately of any unforeseen circumstances arises in the restored teeth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 groups are used One using fibre post placement And the other using surgical extrusion
| Arm | Type | Receives |
|---|---|---|
| Surgical extrusion | Experimental | Procedure: Surgical extrusionNovel and alternative treatment option for horizontal crown root fractured maxillary incisors |
| Fibre post | Active comparator | Device: Fibre postTreatment modality normally used for crown-root fractured tooth |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- patients with complicated crown root fracture
- patients willing for recall
- Good oral hygiene
Key exclusion criteria (2 listed)
- patients not willing for recall
- Patients health rendering root canal treatment
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 |
|---|---|---|
| Surgical extrusionInvasive treatment option for fractured tooth | Procedure or surgery | Surgical extrusion |
| Fibre postEasy approach for treatment | Device | Fibre post |
Primary outcome
Radiographic healing of teeth is measured
Time frame: 18 months
Periapical index score(PAI) is used for assessment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
- Individual participant dataSharing planned: No
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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.
ANAND SHERWOOD, MDS study director
TNMGRMU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical extrusion and Fibre post in people with Fractured Tooth, run by Tamil Nadu Dr.M.G.R.Medical University 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 30 Mar 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact RAHUL BASKAR, MDS (9 1 7598326175, raghulram22@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic healing of teeth is measured (time frame: 18 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 30 Mar 2021.