Partial EdentulismPhase 4NCT02507661
Effect of Alveolar Ridge Preservation on Implant Esthetic Outcomes
A Phase 4 study testing preservation of alveolar ridge with beta tricalcium phosphate + collagen - 2 months, no-preservation of alveolar ridge - 2 months and preservation of alveolar ridge with beta tricalcium phosphate + collagen - 4 months in people with Partial Edentulism, run by University of Belgrade at 1 site in Serbia.
Trial summary
The purpose of this study is to evaluate esthetic outcome of implant supported single crowns after alveolar ridge preservation with beta three calcium phosphate with collagen type I in aesthetic region in upper jaw. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Partial Edentulism
- What is being tested?
- preservation of alveolar ridge with beta tricalcium phosphate + collagen - 2 months, no-preservation of alveolar ridge - 2 months and preservation of alveolar ridge with beta tricalcium phosphate + collagen - 4 months
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSerbia
- Study dates
- Jun 2015to Jan 2018
- Phase
- Phase 4
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy patients according to Classification of American Society of Anesthesiologists (ASA I)
- presence of 4 socket walls
- non-smokers
- good oral hygiene
- good occlusion
Who cannot join
- patients with alveolar ridge height less than 12 mm
- presence of acute or chronic oro-facial pain
- acute periapical infection
- injured soft tissue
- patients who had dental interventions in last 7 days
- patients who had any medications within last 24 hours
- patients with bruxism and para-functions
- patients with allergies to any of applied materials
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Esthetic Outcomes of Implant-supported Crowns After Alveolar Ridge Preservation With Beta Tricalcium Phosphate and Collagen in the Maxillary Esthetic Zone
The purpose of this study is to evaluate esthetic outcome of implant supported single crowns after alveolar ridge preservation with beta three calcium phosphate with collagen type I in aesthetic region in upper jaw.
- Conditions
- Partial Edentulism
- Being tested
- preservation of alveolar ridge with beta tricalcium phosphate + collagen - 2 months, no-preservation of alveolar ridge - 2 months, preservation of alveolar ridge with beta tricalcium phosphate + collagen - 4 months, no-preservation of alveolar ridge - 4 months, preservation of alveolar ridge with beta tricalcium phosphate + collagen - 9 months
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preservation of alveolar ridge with beta tricalcium phosphate + collagen - 2 monthsDrug
no-preservation of alveolar ridge - 2 monthsDrug
preservation of alveolar ridge with beta tricalcium phosphate + collagen - 4 monthsDrug
no-preservation of alveolar ridge - 4 monthsDrug
preservation of alveolar ridge with beta tricalcium phosphate + collagen - 9 monthsProcedure or surgery
no-preservation of alveolar ridge - 9 monthsDrug
| Study group | Role | What they receive |
|---|---|---|
| alveolar ridge preservation - 2 months | Experimental | preservation of alveolar ridge with beta tricalcium phosphate + collagen - 2 months Receives: Drug: preservation of alveolar ridge with beta tricalcium phosphate + collagen - 2 months |
| no-preservation of alveolar ridge - 2 months | Active comparator | no-preservation of alveolar ridge - 2 months Receives: Drug: no-preservation of alveolar ridge - 2 months |
| preservation of alveolar ridge - 4 months | Experimental | preservation of alveolar ridge with beta tricalcium phosphate + collagen - 4 months Receives: Drug: preservation of alveolar ridge with beta tricalcium phosphate + collagen - 4 months |
| no-preservation of alveolar ridge - 4 months | Active comparator | no-preservation of alveolar ridge - 4 months Receives: Drug: no-preservation of alveolar ridge - 4 months |
| preservation of alveolar ridge - 9 months | Experimental | preservation of alveolar ridge with beta tricalcium phosphate + collagen - 9 months Receives: Procedure: preservation of alveolar ridge with beta tricalcium phosphate + collagen - 9 months |
| no-preservation of alveolar ridge - 9 months | Active comparator | no-preservation of alveolar ridge - 9 months Receives: Drug: no-preservation of alveolar ridge - 9 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
implant stability analysis at the time of implant placement
Implant stability will be measured by the resonance frequency analysis
Measured: baseline
implant stability analysis 3 weeks after implant placement
Implant stability will be measured by the resonance frequency analysis
Measured: baseline, 3 weeks
implant stability analysis 6 weeks after implant placement
Implant stability will be measured by the resonance frequency analysis
Measured: baseline, 6 weeks
implant stability analysis 8 weeks after implant placement
Implant stability will be measured by the resonance frequency analysis
Measured: baseline, 8 weeks
change in pink and white esthetic score 2 months of loading
Pink esthetic scale and white esthetic scale will be used for evaluation of changes in white and pink esthetic parameters for implant-supported crowns
Measured: 2 months
change in pink and white esthetic score 6 months of loading
Pink esthetic scale and white esthetic scale will be used for evaluation of changes in white and pink esthetic parameters for implant-supported crowns
Measured: 6 months
change in pink and white esthetic score 12 months of loading
Pink esthetic scale and white esthetic scale will be used for evaluation of changes in white and pink esthetic parameters for implant-supported crowns
Measured: 12 months
Secondary outcomes (3)
analysis of new bone formation 2 months after preservation of alveolar ridge
New bone formation will be assessed by histological analysis and histomorphometrical measurement
Measured: 2 months
analysis of new bone formation 4 months after preservation of alveolar ridge
New bone formation will be assessed by histological analysis and histomorphometrical measurement
Measured: 4 months
analysis of new bone formation 9 months after preservation of alveolar ridge
New bone formation will be assessed by histological analysis and histomorphometrical measurement
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial EdentulismStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Belgrade
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bozidar Brkovic, DDS, MSc, PhD, Professor, University of Belgrade
- Investigators
- Bozidar M Brkovic, PhD, Principal investigator, School of Dental Medicine, University of Belgrade
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02507661
- Sponsor's protocol ID
- 36/21
- Status last verified
- Mar 2018
- First submitted
- 11 Jun 2015
- Last updated
- 23 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esthetic Outcomes of Implant-supported Crowns After Alveolar Ridge Preservation With Beta Tricalcium Phosphate and Collagen in the Maxillary Esthetic Zone
- ClinicalTrials.gov ID
- NCT02507661
- Acronym / sponsor ID
- 36/21
- Conditions
- Partial Edentulism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of BelgradeUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 24 Jul 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.
The purpose of this study is to evaluate esthetic outcome of implant supported single crowns after alveolar ridge preservation with beta three calcium phosphate with collagen type I in aesthetic region in upper jaw.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| alveolar ridge preservation - 2 months | Experimental | Drug: preservation of alveolar ridge with beta tricalcium phosphate + collagen - 2 monthspreservation of alveolar ridge with beta tricalcium phosphate + collagen - 2 months |
| no-preservation of alveolar ridge - 2 months | Active comparator | Drug: no-preservation of alveolar ridge - 2 monthsno-preservation of alveolar ridge - 2 months |
| preservation of alveolar ridge - 4 months | Experimental | Drug: preservation of alveolar ridge with beta tricalcium phosphate + collagen - 4 monthspreservation of alveolar ridge with beta tricalcium phosphate + collagen - 4 months |
| no-preservation of alveolar ridge - 4 months | Active comparator | Drug: no-preservation of alveolar ridge - 4 monthsno-preservation of alveolar ridge - 4 months |
| preservation of alveolar ridge - 9 months | Experimental | Procedure: preservation of alveolar ridge with beta tricalcium phosphate + collagen - 9 monthspreservation of alveolar ridge with beta tricalcium phosphate + collagen - 9 months |
| no-preservation of alveolar ridge - 9 months | Active comparator | Drug: no-preservation of alveolar ridge - 9 monthsno-preservation of alveolar ridge - 9 months |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- healthy patients according to Classification of American Society of Anesthesiologists (ASA I)
- presence of 4 socket walls
- non-smokers
- good oral hygiene
- good occlusion
Key exclusion criteria (8 listed)
- patients with alveolar ridge height less than 12 mm
- presence of acute or chronic oro-facial pain
- acute periapical infection
- injured soft tissue
- patients who had dental interventions in last 7 days
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 |
|---|---|---|
| preservation of alveolar ridge with beta tricalcium phosphate + collagen - 2 months | Drug | alveolar ridge preservation - 2 months |
| no-preservation of alveolar ridge - 2 months | Drug | no-preservation of alveolar ridge - 2 months |
| preservation of alveolar ridge with beta tricalcium phosphate + collagen - 4 months | Drug | preservation of alveolar ridge - 4 months |
| no-preservation of alveolar ridge - 4 months | Drug | no-preservation of alveolar ridge - 4 months |
| preservation of alveolar ridge with beta tricalcium phosphate + collagen - 9 months | Procedure or surgery | preservation of alveolar ridge - 9 months |
| no-preservation of alveolar ridge - 9 months | Drug | no-preservation of alveolar ridge - 9 months |
Primary outcome
implant stability analysis at the time of implant placement
Time frame: baseline
Implant stability will be measured by the resonance frequency analysis
implant stability analysis 3 weeks after implant placement
Time frame: baseline, 3 weeks
Implant stability will be measured by the resonance frequency analysis
implant stability analysis 6 weeks after implant placement
Time frame: baseline, 6 weeks
Implant stability will be measured by the resonance frequency analysis
implant stability analysis 8 weeks after implant placement
Time frame: baseline, 8 weeks
Implant stability will be measured by the resonance frequency analysis
change in pink and white esthetic score 2 months of loading
Time frame: 2 months
Pink esthetic scale and white esthetic scale will be used for evaluation of changes in white and pink esthetic parameters for implant-supported crowns
change in pink and white esthetic score 6 months of loading
Time frame: 6 months
Pink esthetic scale and white esthetic scale will be used for evaluation of changes in white and pink esthetic parameters for implant-supported crowns
change in pink and white esthetic score 12 months of loading
Time frame: 12 months
Pink esthetic scale and white esthetic scale will be used for evaluation of changes in white and pink esthetic parameters for implant-supported crowns
3 secondary outcomes
analysis of new bone formation 2 months after preservation of alveolar ridge
Time frame: 2 months
analysis of new bone formation 4 months after preservation of alveolar ridge
Time frame: 4 months
analysis of new bone formation 9 months after preservation of alveolar ridge
Time frame: 9 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 23 Mar 2018.
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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.
Bozidar M Brkovic, PhD principal investigator
School of Dental Medicine, University of Belgrade
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing preservation of alveolar ridge with beta tricalcium phosphate + collagen - 2 months, no-preservation of alveolar ridge - 2 months and preservation of alveolar ridge with beta tricalcium phosphate + collagen - 4 months in people with Partial Edentulism, run by University of Belgrade at 1 site in Serbia.
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 8 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 23 Mar 2018. 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 Serbia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
implant stability analysis at the time of implant placement (time frame: baseline). The study lists 7 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 23 Mar 2018.