Decayed TeethNCT04933409
3D Printed Donor Tooth Replica in Autotransplantation of Teeth
A study testing 3D printed replica of the donor tooth and Conventional Autotransplantation of tooth in people with Decayed Teeth, run by College of Medical Sciences Teaching Hospital. Nepal.
Trial summary
3D printed replicas of the donor tooth can reduce extraoral time during the autotransplantation of teeth, which can reduce dehydration and manipulation of periodontal tissue of the donor tooth, thus possibly increasing the success rate. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Decayed Teeth
- What is being tested?
- 3D printed replica of the donor tooth and Conventional Autotransplantation of tooth
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2021to 1 Mar 2022
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- patient presenting with decayed first molars
- autotransplantation of third molar at the recipient site
Who cannot join
- Diabetic, pregnant patients
- other autotransplantations (other than first molar recipient and third molar donor)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 3D Printed Donor Tooth Replica in Autotransplantation of Teeth. A Randomized Clinical Trial.
3D printed replicas of the donor tooth can reduce extraoral time during the autotransplantation of teeth, which can reduce dehydration and manipulation of periodontal tissue of the donor tooth, thus possibly increasing the success rate.
Read the detailed description
This technique of autotransplantation has been innovated using 3-dimensional (3D) imaging and rapid prototyping.The use of a 3D-printed replica of the donor tooth is thought to minimize the risk of iatrogenic damage to the actual donor tooth. Nevertheless, no large prospective and comparative studies are available to assess the outcomes using these 3D techniques. Therefore, this study aimed to compare 3D printed replicas in autotransplantation of teeth, compared to the conventional technique. The present study will evaluate the feasibility, clinical satisfied accuracy, and stability of a novel approach for computer-aided autotransplantation of teeth. This new approach facilitated the surgical procedure and might be a viable and predictable method for autotransplantation of teeth.
Application of printed 3D replicas of transplanted teeth facilitates surgical preparation of the recipient site, shortens the extra-alveolar time, and reduces the minimum the number of attempts of the donor tooth insertion at the prepared socket. Their use can significantly decrease the risk of damage to the root surface of a transplant, thus increasing the chance of success.
- Conditions
- Decayed Teeth
- Being tested
- 3D printed replica of the donor tooth, Conventional Autotransplantation of tooth
- Keywords
- decayed teeth; autotransplantation; 3d printing
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D printed replica of the donor toothProcedure or surgery
3D printed replica of the donor tooth.
Conventional Autotransplantation of toothProcedure or surgery
Conventional Autotransplantation of tooth without using the 3D printed guide
| Study group | Role | What they receive |
|---|---|---|
| 3D printed replica of Donor tooth | Experimental | 3D printed replica of Donor tooth Receives: Procedure: 3D printed replica of the donor tooth |
| Conventional | Active comparator | Conventional method of autotransplantation. Receives: Procedure: Conventional Autotransplantation of tooth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of teeth that fail
reduced mobility (less than grade II) after 2 weeks of autotransplantation
Measured: two weeks
Operative time
Operative time from the start of socket preparation at the recipient site
Measured: 1 day
Rate of Ankylosis (replacement resorption)
Ankylosis (replacement resorption)
Measured: 6 months
Rate of root resorption
infection related root resorption
Measured: 6 months
Secondary outcomes (1)
Cost difference of the treatment
Cost of 3D printing
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start1 Oct 2021 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decayed TeethStudies 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
- Parallel randomized controlled tria
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- College of Medical Sciences Teaching Hospital. Nepal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashutosh Kumar Singh, College of Medical Sciences Teaching Hospital. Nepal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04933409
- Sponsor's protocol ID
- IOM1
- Status last verified
- Sep 2021
- First submitted
- 17 Jun 2021
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Yes, On request to the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Printed Donor Tooth Replica in Autotransplantation of Teeth. A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT04933409
- Acronym / sponsor ID
- IOM1
- Conditions
- Decayed Teeth
- Keywords
- decayed teeth; autotransplantation; 3d printing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- College of Medical Sciences Teaching Hospital. NepalUniversity, hospital or other
- Study start
- 1 Oct 2021 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 21 Jun 2021 (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.
3D printed replicas of the donor tooth can reduce extraoral time during the autotransplantation of teeth, which can reduce dehydration and manipulation of periodontal tissue of the donor tooth, thus possibly increasing the success rate.
Detailed description
This technique of autotransplantation has been innovated using 3-dimensional (3D) imaging and rapid prototyping.The use of a 3D-printed replica of the donor tooth is thought to minimize the risk of iatrogenic damage to the actual donor tooth. Nevertheless, no large prospective and comparative studies are available to assess the outcomes using these 3D techniques. Therefore, this study aimed to compare 3D printed replicas in autotransplantation of teeth, compared to the conventional technique. The present study will evaluate the feasibility, clinical satisfied accuracy, and stability of a novel approach for computer-aided autotransplantation of teeth. This new approach facilitated the surgical procedure and might be a viable and predictable method for autotransplantation of teeth.
Application of printed 3D replicas of transplanted teeth facilitates surgical preparation of the recipient site, shortens the extra-alveolar time, and reduces the minimum the number of attempts of the donor tooth insertion at the prepared socket. Their use can significantly decrease the risk of damage to the root surface of a transplant, thus increasing the chance of success.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel randomized controlled tria
| Arm | Type | Receives |
|---|---|---|
| 3D printed replica of Donor tooth | Experimental | Procedure: 3D printed replica of the donor tooth3D printed replica of Donor tooth |
| Conventional | Active comparator | Procedure: Conventional Autotransplantation of toothConventional method of autotransplantation. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- patient presenting with decayed first molars
- autotransplantation of third molar at the recipient site
Key exclusion criteria (2 listed)
- Diabetic, pregnant patients
- other autotransplantations (other than first molar recipient and third molar donor)
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 |
|---|---|---|
| 3D printed replica of the donor tooth3D printed replica of the donor tooth. | Procedure or surgery | 3D printed replica of Donor tooth |
| Conventional Autotransplantation of toothConventional Autotransplantation of tooth without using the 3D printed guide | Procedure or surgery | Conventional |
Primary outcome
Number of teeth that fail
Time frame: two weeks
reduced mobility (less than grade II) after 2 weeks of autotransplantation
Operative time
Time frame: 1 day
Operative time from the start of socket preparation at the recipient site
Rate of Ankylosis (replacement resorption)
Time frame: 6 months
Ankylosis (replacement resorption)
Rate of root resorption
Time frame: 6 months
infection related root resorption
1 secondary outcome
Cost difference of the treatment
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Individual participant dataSharing planned: Yes. Yes, On request to the principal investigator.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing 3D printed replica of the donor tooth and Conventional Autotransplantation of tooth in people with Decayed Teeth, run by College of Medical Sciences Teaching Hospital. Nepal.
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 2 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 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Ashutosh K Singh, MDS (+9779804244369, dr.ashutosh@iom.edu.np), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of teeth that fail (time frame: two weeks). The study lists 4 primary outcomes in all. 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 5 Sep 2021.