Dental CrownNCT02609178
Basic Study of Fabricating Biomorphic Crowns
A study testing FGP and AVR in people with Dental Crown and Prosthesis, run by Air Force Military Medical University, China at 1 site in China.
Trial summary
The purpose of this study is to compare among different designs of the occlusal surface of artificial crowns, trying to determine a guidance of fabricating artificial crowns with better mimesis of the original tooth crown in terms of morphology. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Crown, Prosthesis
- What is being tested?
- FGP and AVR
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- Dec 2015to Mar 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- single crown restoration needed in posterior quadrants
- the antagonist of the abutment tooth is purely natural or received minimum restorations that does not change its morphology too much
- no orthodontic treatment history
- stable occlusion
- no parafunctional movements existed
Who cannot join
- sequential crown restorations needed
- the morphology of the antagonist of the abutment tooth has been largely changed by previous treatment
- no contact exists between the abutment tooth and its antagonist
- orthodontic treatment history
- unstable occlusion
- existed parafunctional movements
- participated in other clinical studies
Trial locations and contacts
1 site in 1 country.
China1 site
Stomatological Hospital of Fourth Military Medical University
Xi’an, Shanxi, 710032
About this study
Official title: Comparative Evaluation of Different Occlusal Surface Designs of Artificial Crown
The purpose of this study is to compare among different designs of the occlusal surface of artificial crowns, trying to determine a guidance of fabricating artificial crowns with better mimesis of the original tooth crown in terms of morphology.
Read the detailed description
For occlusal surface design, each subject would be given 3 crowns using different fabricating guidance -- the FGP technique(FGP),the average setting technique(AVR) and conventional technique(CON), separately. Upon baseline visit, general tooth preparation procedures would be performed, including impression taking before and after treatment and tooth preparation. Sometimes photo taking is needed. On try-in visit, subjects would be ask to fill in questionaires(Likert's scale) and the adjusting time for each crown would be recorded. Moreover, t-scan would be used to assess the occlusal equilibrium. All in all, including adjusting visit for FGP, the subjects have to visit the clinic for 3 times which would take them 3-week time.
The Institutional Board(IRB) of the Stomatological Hospital of Fourth Military Medical University(FMMU) would be in supervision of the whole study and is responsible for the quality assurance plan, data check and source data verification.
Subject recruitment would done within those patients visit the department of prosthodontics of the Stomatological Hospital of FMMU and have an interest towards this study. One clinician would be appointed to enroll the subjects according to the standards. To avoid errors, all the examinations done in the study shall be accomplished by the same clinician and the crowns fabricated in the study shall be designed by the same technician. The clinician and the technician participated would receive adequate training before the study to ensure their performance. Every subject in the study should assign informed consents at the beginning of the study and establish case report forms(CRFs). During the study, if adverse events(such as crown chipping, crown dropping or iatrogenic gingivitis, etc) happen, subjects are required to contact the investigator within 24 hours; and the investigator should then report to the IRB within 24 hours. Following treatment or compensation would be done according to the clauses stated in the informed consent signed by the subjects.
The whole study needs subjects in total. During the study, subjects have their own right to quit the study at any time if they have discussed with the investigator in advance. These subjects then are deemed as "unavailable". If subjects don't contact the investigator and quit the study(the investigators can't contact them within the follow-up period), their records then are deemed as "missing".
All the information collected in the study would be protected and only be used within this study. The statistical analysis of this study would be processed with the aid of the department of statistics of FMMU.
- Conditions
- Dental Crown, Prosthesis
- Being tested
- FGP, AVR
- Keywords
- artificial crown, biomorphic, functional generated path, muscle-action theory, anatomic theory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FGPProcedure or surgery
Also called general
To execute FGP technique, the occlusal surface of the interim should be back cut to leave at least 1mm occlusal space. Then apply the recording resin. Ask the subjects to close the mouth to maximum intercuspal position then perform right lateral, left lateral and protrusive movements in succession ending in maximum intercuspation position. Excessive resin then should be trimmed off and Bausch articulating paper would be used to mark the intercuspal contacts. Zinc oxide is then applied to check eccentric occlusion, trimmed off resin if there're interferences. Then the interim would be used as a copy to design the occlusal surface of the crown. (CAD/CAM)
AVRProcedure or surgery
Also called average value
the crowns in this group would be designed by setting virtual articulator to average mode (CAD/CAM)
| Study group | Role | What they receive |
|---|---|---|
| FGP design (FGP, AVR) | Experimental | use functional generated path to execute different occlusal surface designs of the artificial crown and evaluate its efficacy Receives: Procedure: FGP; Procedure: AVR |
| conventional design (CON) | No intervention | use conventional method to execute different occlusal surface designs of the artificial crown and evaluate its efficacy |
What is being measured
The primary outcome is the main question the study is designed to answer.
△OT Value
Occlusion time (OT) is defined as the time from the first contact of occluding teeth to maximum intercuspation. OT is directly related with patients' occlusal contact pattern; and some have considered it as a capable description of occlusion.
In the study, the OT value of each crown would be assessed before try-in (baseline) and immediately after try-in using T-scan (FGP, AVR, CON). Try-in procedure would be finished by the same clinician.
△OT was calculated for minimizing individual difference among participants. The equation for △OT was:△OT(FGP/ AVR/ CON)= OT (FGP/ AVR/ CON)-OT(baseline)
Measured: 2 weeks(plus or minus 7 days) after tooth preparation
△DT Value
Disocclusion time (DT) is defined as the time from maximum intercuspation to complete disocclusion during lateral movement. DT related tooth contacts with muscle activity. Abnormities in DT would result in change of muscle activity, thus facilitate the occurrence of temporomandibular joint disorders.
In the study, the DT value of each crown would be assessed before try-in (baseline) and immediately after try-in using T-scan (FGP, AVR, CON). Try-in procedure would be finished by the same clinician.
△DT was calculated for minimizing individual difference among participants. The equation for △DT was: △DT(FGP/ AVR/ CON)= DT (FGP/ AVR/ CON)-DT(baseline)
Measured: 2 weeks(plus or minus 7 days) after tooth preparation
Secondary outcomes (2)
Occlusal Adjusting Time for Crowns
Try-in procedure would be finished by the same clinician. The occlusal adjusting time would be counted using a timer and recorded.
Measured: 2 weeks(plus or minus 7 days) after tooth preparation
Likert's Scale
The questionaire was designed to evaluate participants' feeling towards the occlusal interference. It would be given to the subject after immediately try-in the crowns. In the questionaire:
Score 0 = No interference (feel comfortable while biting on the artificial crown) Score 1 = Moderate interference(could feel the artificial crown is higher when biting on the artificial crown, but when firmly clenched, the upper teeth could bite on the lower ones) Score 2 = High interference(the artificial teeth is higher that the upper teeth couldn't bite on all the lower teeth when firmly clenched)
Measured: 2 weeks(plus or minus 7 days) after tooth preparation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startDec 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Dental CrownStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji-hua Chen, Air Force Military Medical University, China
- Investigators
- Jihua Chen, PhD, Study chair, Stomatological Hospital of FMMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02609178
- Sponsor's protocol ID
- IRB-REV-2015039
- Status last verified
- Jun 2016
- First submitted
- 16 Nov 2015
- Last updated
- 2 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Mehl A. A new concept for the integration of dynamic occlusion in the digital construction process. Int J Comput Dent. 2012;15(2):109-23. English, German.
PubMed 22891415Ikeda A, Miura H, Okada D, Tokuda A, Shinogaya T. The effect of occlusal contacts on adjacent tooth. J Med Dent Sci. 2005 Dec;52(4):195-202.
PubMed 16669453Alhouri N, Watts DC, McCord JF, Smith PW. Mathematical analysis of tooth and restoration contour using image analysis. Dent Mater. 2004 Nov;20(9):893-9. doi: 10.1016/j.dental.2004.06.003.
PubMed 15451245Vasconcelos FS, Neves AC, Silva-Concilio LR, Cunha LG, Rode Sde M. Influence of anatomic reference on the buccal contour of prosthetic crowns. Braz Oral Res. 2009 Jul-Sep;23(3):230-5. doi: 10.1590/s1806-83242009000300002.
PubMed 19893955Kohal RJ, Gerds T, Strub JR. Effect of different crown contours on periodontal health in dogs. Clinical results. J Dent. 2003 Aug;31(6):407-13. doi: 10.1016/s0300-5712(03)00070-8.
PubMed 12878023Takada J, Ono T, Miyamoto JJ, Yokota T, Moriyama K. Association between intraoral pressure and molar position and inclination in subjects with facial asymmetry. Eur J Orthod. 2011 Jun;33(3):243-9. doi: 10.1093/ejo/cjq060. Epub 2010 Sep 9.
PubMed 20829312Olthoff L, Meijer I, de Ruiter W, Bosman F, van der Zel J. Effect of virtual articulator settings on occlusal morphology of CAD/CAM restorations. Int J Comput Dent. 2007 Apr;10(2):171-85. English, German.
PubMed 17899892Memon S. A Comparative Evaluation of the Effect of Double Casting Technique Using Functionally Generated Path and Conventional Single Casting with Respect to Functional Articulation, Patient Satisfaction and Chair Side Time, in Single Unit Molar Teeth: An In Vivo Study. J Indian Prosthodont Soc. 2014 Dec;14(Suppl 1):119-25. doi: 10.1007/s13191-014-0379-6. Epub 2014 Jul 10.
PubMed 26199501Curtis SR. Functionally generated paths for ceramometal restorations. J Prosthet Dent. 1999 Jan;81(1):33-6. doi: 10.1016/s0022-3913(99)70232-5.
PubMed 9878972Wiklund L, Rossi F, Strata P, van der Want JJ. The rat olivocerebellar system visualized in detail with anterograde PHA-L tracing technique, and sprouting of climbing fibers demonstrated after subtotal olivary lesions. Eur J Morphol. 1990;28(2-4):256-67.
PubMed 2245134Ender A, Mormann WH, Mehl A. Efficiency of a mathematical model in generating CAD/CAM-partial crowns with natural tooth morphology. Clin Oral Investig. 2011 Apr;15(2):283-9. doi: 10.1007/s00784-010-0384-z. Epub 2010 Feb 9.
PubMed 20143242Becker CM, Kaldahl WB. Current theories of crown contour, margin placement, and pontic design. 1981. J Prosthet Dent. 2005 Feb;93(2):107-15. doi: 10.1016/j.prosdent.2004.11.005. No abstract available.
PubMed 15674218Hazen SP, Osborne JW. Relationship of operative dentistry to periodontal health. Dent Clin North Am. 1967 Mar:245-54. No abstract available.
PubMed 5225601Yuodelis RA, Weaver JD, Sapkos S. Facial and lingual contours of artificial complete crown restorations and their effects on the periodontium. J Prosthet Dent. 1973 Jan;29(1):61-6. doi: 10.1016/0022-3913(73)90140-6. No abstract available.
PubMed 4564800Koidis PT, Burch JG, Melfi RC. Clinical crown contours: contemporary view. J Am Dent Assoc. 1987 Jun;114(6):792-5. doi: 10.14219/jada.archive.1987.0189.
PubMed 3301975
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Different Occlusal Surface Designs of Artificial Crown
- ClinicalTrials.gov ID
- NCT02609178
- Acronym / sponsor ID
- IRB-REV-2015039
- Conditions
- Dental Crown, Prosthesis
- Keywords
- artificial crown, biomorphic, functional generated path, muscle-action theory, anatomic theory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 20 Nov 2015 (estimated)
- Results
- Posted 2 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare among different designs of the occlusal surface of artificial crowns, trying to determine a guidance of fabricating artificial crowns with better mimesis of the original tooth crown in terms of morphology.
Detailed description
For occlusal surface design, each subject would be given 3 crowns using different fabricating guidance -- the FGP technique(FGP),the average setting technique(AVR) and conventional technique(CON), separately. Upon baseline visit, general tooth preparation procedures would be performed, including impression taking before and after treatment and tooth preparation. Sometimes photo taking is needed. On try-in visit, subjects would be ask to fill in questionaires(Likert's scale) and the adjusting time for each crown would be recorded. Moreover, t-scan would be used to assess the occlusal equilibrium. All in all, including adjusting visit for FGP, the subjects have to visit the clinic for 3 times which would take them 3-week time.
The Institutional Board(IRB) of the Stomatological Hospital of Fourth Military Medical University(FMMU) would be in supervision of the whole study and is responsible for the quality assurance plan, data check and source data verification.
Subject recruitment would done within those patients visit the department of prosthodontics of the Stomatological Hospital of FMMU and have an interest towards this study. One clinician would be appointed to enroll the subjects according to the standards. To avoid errors, all the examinations done in the study shall be accomplished by the same clinician and the crowns fabricated in the study shall be designed by the same technician. The clinician and the technician participated would receive adequate training before the study to ensure their performance. Every subject in the study should assign informed consents at the beginning of the study and establish case report forms(CRFs). During the study, if adverse events(such as crown chipping, crown dropping or iatrogenic gingivitis, etc) happen, subjects are required to contact the investigator within 24 hours; and the investigator should then report to the IRB within 24 hours. Following treatment or compensation would be done according to the clauses stated in the informed consent signed by the subjects.
The whole study needs subjects in total. During the study, subjects have their own right to quit the study at any time if they have discussed with the investigator in advance. These subjects then are deemed as "unavailable". If subjects don't contact the investigator and quit the study(the investigators can't contact them within the follow-up period), their records then are deemed as "missing".
All the information collected in the study would be protected and only be used within this study. The statistical analysis of this study would be processed with the aid of the department of statistics of FMMU.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FGP design (FGP, AVR) | Experimental | Procedure: FGP, Procedure: AVRuse functional generated path to execute different occlusal surface designs of the artificial crown and evaluate its efficacy |
| conventional design (CON) | No intervention | –use conventional method to execute different occlusal surface designs of the artificial crown and evaluate its efficacy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- single crown restoration needed in posterior quadrants
- the antagonist of the abutment tooth is purely natural or received minimum restorations that does not change its morphology too much
- no orthodontic treatment history
- stable occlusion
- no parafunctional movements existed
Key exclusion criteria (7 listed)
- sequential crown restorations needed
- the morphology of the antagonist of the abutment tooth has been largely changed by previous treatment
- no contact exists between the abutment tooth and its antagonist
- orthodontic treatment history
- unstable occlusion
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 |
|---|---|---|
| FGPAlso: generalTo execute FGP technique, the occlusal surface of the interim should be back cut to leave at least 1mm occlusal space. Then apply the recording resin. Ask the subjects to close the mouth to maximum intercuspal position then perform right lateral, left lateral and protrusive movements in succession ending in maximum intercuspation position. Excessive resin then should be trimmed off and Bausch articulating paper would be used to mark the intercuspal contacts. Zinc oxide is then applied to check eccentric occlusion, trimmed off resin if there're interferences. Then the interim would be used as a copy to design the occlusal surface of the crown. (CAD/CAM) | Procedure or surgery | FGP design (FGP, AVR) |
| AVRAlso: average valuethe crowns in this group would be designed by setting virtual articulator to average mode (CAD/CAM) | Procedure or surgery | FGP design (FGP, AVR) |
Primary outcome
△OT Value
Time frame: 2 weeks(plus or minus 7 days) after tooth preparation
Occlusion time (OT) is defined as the time from the first contact of occluding teeth to maximum intercuspation. OT is directly related with patients' occlusal contact pattern; and some have considered it as a capable description of occlusion. In the study, the OT value of each crown would be assessed before try-in (baseline) and immediately after try-in using T-scan (FGP, AVR, CON). Try-in procedure would be finished by the same clinician. △OT was calculated for minimizing individual difference among participants. The equation for △OT was:△OT(FGP/ AVR/ CON)= OT (FGP/ AVR/ CON)-OT(baseline)
△DT Value
Time frame: 2 weeks(plus or minus 7 days) after tooth preparation
Disocclusion time (DT) is defined as the time from maximum intercuspation to complete disocclusion during lateral movement. DT related tooth contacts with muscle activity. Abnormities in DT would result in change of muscle activity, thus facilitate the occurrence of temporomandibular joint disorders. In the study, the DT value of each crown would be assessed before try-in (baseline) and immediately after try-in using T-scan (FGP, AVR, CON). Try-in procedure would be finished by the same clinician. △DT was calculated for minimizing individual difference among participants. The equation for △DT was: △DT(FGP/ AVR/ CON)= DT (FGP/ AVR/ CON)-DT(baseline)
2 secondary outcomes
Occlusal Adjusting Time for Crowns
Time frame: 2 weeks(plus or minus 7 days) after tooth preparation
Likert's Scale
Time frame: 2 weeks(plus or minus 7 days) after tooth preparation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22891415Mehl A. A new concept for the integration of dynamic occlusion in the digital construction process. Int J Comput Dent. 2012;15(2):109-23. English, German.
- Background: PubMed 16669453Ikeda A, Miura H, Okada D, Tokuda A, Shinogaya T. The effect of occlusal contacts on adjacent tooth. J Med Dent Sci. 2005 Dec;52(4):195-202.
- Background: PubMed 15451245Alhouri N, Watts DC, McCord JF, Smith PW. Mathematical analysis of tooth and restoration contour using image analysis. Dent Mater. 2004 Nov;20(9):893-9. doi: 10.1016/j.dental.2004.06.003.
- Background: PubMed 19893955Vasconcelos FS, Neves AC, Silva-Concilio LR, Cunha LG, Rode Sde M. Influence of anatomic reference on the buccal contour of prosthetic crowns. Braz Oral Res. 2009 Jul-Sep;23(3):230-5. doi: 10.1590/s1806-83242009000300002.
- Background: PubMed 12878023Kohal RJ, Gerds T, Strub JR. Effect of different crown contours on periodontal health in dogs. Clinical results. J Dent. 2003 Aug;31(6):407-13. doi: 10.1016/s0300-5712(03)00070-8.
- Background: PubMed 20829312Takada J, Ono T, Miyamoto JJ, Yokota T, Moriyama K. Association between intraoral pressure and molar position and inclination in subjects with facial asymmetry. Eur J Orthod. 2011 Jun;33(3):243-9. doi: 10.1093/ejo/cjq060. Epub 2010 Sep 9.
- Background: PubMed 17899892Olthoff L, Meijer I, de Ruiter W, Bosman F, van der Zel J. Effect of virtual articulator settings on occlusal morphology of CAD/CAM restorations. Int J Comput Dent. 2007 Apr;10(2):171-85. English, German.
- Background: PubMed 26199501Memon S. A Comparative Evaluation of the Effect of Double Casting Technique Using Functionally Generated Path and Conventional Single Casting with Respect to Functional Articulation, Patient Satisfaction and Chair Side Time, in Single Unit Molar Teeth: An In Vivo Study. J Indian Prosthodont Soc. 2014 Dec;14(Suppl 1):119-25. doi: 10.1007/s13191-014-0379-6. Epub 2014 Jul 10.
- Background: PubMed 9878972Curtis SR. Functionally generated paths for ceramometal restorations. J Prosthet Dent. 1999 Jan;81(1):33-6. doi: 10.1016/s0022-3913(99)70232-5.
- Background: PubMed 2245134Wiklund L, Rossi F, Strata P, van der Want JJ. The rat olivocerebellar system visualized in detail with anterograde PHA-L tracing technique, and sprouting of climbing fibers demonstrated after subtotal olivary lesions. Eur J Morphol. 1990;28(2-4):256-67.
- Background: PubMed 20143242Ender A, Mormann WH, Mehl A. Efficiency of a mathematical model in generating CAD/CAM-partial crowns with natural tooth morphology. Clin Oral Investig. 2011 Apr;15(2):283-9. doi: 10.1007/s00784-010-0384-z. Epub 2010 Feb 9.
- Background: PubMed 15674218Becker CM, Kaldahl WB. Current theories of crown contour, margin placement, and pontic design. 1981. J Prosthet Dent. 2005 Feb;93(2):107-15. doi: 10.1016/j.prosdent.2004.11.005. No abstract available.
- Functional Occlusion: From TMJ to Smile Design by Peter E. Dawson DDSLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Jihua Chen, PhD study chair
Stomatological Hospital of FMMU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FGP and AVR in people with Dental Crown and Prosthesis, run by Air Force Military Medical University, China at 1 site in China.
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 5 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 2 Aug 2016. 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 China. 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?
Yes. Results are posted in the registry (first posted 2 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
△OT Value (time frame: 2 weeks(plus or minus 7 days) after tooth preparation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02609178, which also lists 17 linked publications.
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 2 Aug 2016.