Tooth ExtractionPhase 2RPNCT02155764
Ridge Preservation With New Class of Osteoplastic Materials
A Phase 2 study testing Octacalcium phosphate, Bio-Oss and Tricalcium phosphate in people with Tooth Extraction and Atrophy of Edentulous Alveolar Ridge, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
Trial summary
Return to normal life and shortening rehabilitation period of patients after surgical removal of teeth is important and urgent social problem. In this regard, higher demands for quality of care and treatment of patients, which requires the development of new approaches to the treatment of patients, the introduction of… Read more about this study
- Who is it for?
- Ages 17 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Extraction, Atrophy of Edentulous Alveolar Ridge
- What is being tested?
- Octacalcium phosphate, Bio-Oss and Tricalcium phosphate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteRussia
- Study dates
- 1 Sep 2016to 1 Apr 2019
- Phase
- Phase 2
- 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 17 to 85 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patient must have voluntarily signed the informed consent
- Males and females, 18 years to 75 years of age
- Patient needs single tooth extraction in mandibular or maxillary incisor or pre-molar region and would benefit from prosthetic reconstruction with a dental implant
- Patients must be committed to the study and must sign informed consent
- Patient in good general health as documented by self assessment
Who cannot join
- Systemic exclusion criteria:
- Patient who has any known diseases (not including controlled diabetes mellitus), infections or recent surgical procedures within 30 days of study initiation
- Female patient who are pregnant or lactating or of child bearing potential not using acceptable methods of birth control (hormonal, barriers or abstinence
- Patient who are on chronic treatment (i.e., two weeks or more) with any medication known to affect oral status (e.g., phenytoin, dihydropyridine calcium antagonists, cyclosporine, and non-steroidal anti-inflammatory drugs) within one month of baseline visit
- Patient who knowingly has HIV or Hepatitis
- Alcoholism or chronically drug abuse causing systemic compromisation
Show all 15Show fewer
- Patient who is a heavy smoker (>10/cigarettes per day).
- Local exclusion criteria
- Uncontrolled or untreated periodontal disease
- Patient who has a full mouth plaque level >30 % at the enrolment visit
- History of local radiation therapy
- Presence of oral lesions (such as ulceration, malignancy)
- Persistent intraoral infection
- Patients presenting clinical and radiological signs and symptoms of maxillary sinus disease
- Patient presents an acute endodontic lesion in the test tooth or in the neighbouring areas to the experimental procedure (sites with presence of an asymptomatic chronic lesion are eligible)
Trial locations and contacts
1 site in 1 country.
Russia1 site
Cental Scientific Research Institute of Dentistry and Maxillo-facial Surgery
Moscow, RU, 119991
About this study
Official title: Comparison of Octacalcium Phosphate Synthetic Bone Graft (OctoFor) and Bovine-derived Bone (Bio-Oss) for Ridge Preservation After Tooth Extraction: Open, Prospective, Non-Randomised Clinical Trial
Return to normal life and shortening rehabilitation period of patients after surgical removal of teeth is important and urgent social problem. In this regard, higher demands for quality of care and treatment of patients, which requires the development of new approaches to the treatment of patients, the introduction of new technologies and the associated development of new materials . Serious problem of contemporary oral and maxillo-facial surgery and dentistry is augmentation of bone defects generated during the surgical treatment of diseases and injuries of the bones. The results of surgical repair of bone defects are more dependent on the course of the process of reparative osteogenesis. Long-term periods of clinical studies indicate that reparative osteogenesis in posttraumatic bone defects is slow - months and years, and in some cases no bone defects filled with bone tissue.
This project aims at addressing the preservation of bone volume in humans after tooth extraction using biomaterials with optimum performance. The practical significance of the project is to establish an effective tissue response and, thus, possible subsequent quality installation of dental implants. The proposed solution is based on the scientific development of the operative techniques, and a comparative analysis of several classes of biomaterials (xenogenic and synthetic analogs), including the use of biological precursors of bone apatite mineralization having osteoinductive (stimulating) properties.
- Being tested
- Octacalcium phosphate, Bio-Oss, Tricalcium phosphate
- Keywords
- tooth, extraction, alveolar socket, socket preservation, ridge preservation, bone graft, tricalcium phosphate, octacalcium phosphate, xenograft, bio oss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Octacalcium phosphateDevice
Also called OctoFor
Bone augmentation, after tooth extraction, with Octacalcium Phosphate (synthetic bone graft material) in combination with resorbable collagen membrane Bio-Gide.
Bio-OssDevice
Bone augmentation, after tooth extraction, with Bio-Oss (bovine-derived xenograft)in combination with resorbable collagen membrane Bio-Gide
Tricalcium phosphateDevice
Also called TriCafor
Bone augmentation, after tooth extraction, with Tricalcium Phosphate (synthetic bone graft material) in combination with resorbable collagen membrane Bio-Gide.
| Study group | Role | What they receive |
|---|---|---|
| Octacalcium phosphate | Experimental | Bone augmentation, after tooth extraction, with Octacalcium phosphate (synthetic bone graft material) in combination with resorbable collagen membrane Bio-Gide. Receives: Device: Octacalcium phosphate |
| Bio-Oss | Active comparator | Bone augmentation, after tooth extraction, with Bio-Oss (bovine-derived xenograft)in combination with resorbable collagen membrane Bio-Gide Receives: Device: Bio-Oss |
| Tricalcium phosphate | Active comparator | Bone augmentation, after tooth extraction, with Tricalcium phosphate (synthetic bone graft material) in combination with resorbable collagen membrane Bio-Gide. Receives: Device: Tricalcium phosphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes of bone level between baseline and 3 months post-extraction at the time of implantation
A prefabricated stent will be used as an anchor point. After tooth extraction size of dehiscence of buccal bone from anchor point to the alveolar crest will be measured (baseline). Socket will be filled with biomaterial. After 3 months of healing at the time of implant placement the same stent will be used as an anchor point to measure size of dehiscence after socket preservation.
Measured: baseline and 3 months post-extraction
Secondary outcomes (1)
Percent new vital bone formation
Bone core biopsy will be evaluated histologically for percent new vital bone formation at the time of implantation
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2014 (estimated)
- Study start1 Sep 2016
- Primary completion1 Dec 2018
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Tooth ExtractionStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Central Scientific Research Institute of Dentistry and Maxillo-facial Surgery, Moscow, Russia, Bionova, Skolkovo Community, Russia
- Responsible party
- Principal investigator, Alex Gurin, I.M. Sechenov First Moscow State Medical University
- Investigators
- Anatoly Kulakov, Prof, Study director, Central Scientific Research Institute of Dentistry and Maxillo-facial Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02155764
- Sponsor's protocol ID
- 11-13
- Other IDs
- 11-13
- Acronym
- RP
- Status last verified
- Apr 2019
- First submitted
- 29 May 2014
- Last updated
- 22 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gurin AN, Komlev VS, Fadeeva IV, Petrakiva NV, Varda NS. [A comparative study of bone regeneration potency of alfa and beta-tricalcium phosphate bone substitute materials]. Stomatologiia (Mosk). 2012;91(6):16-21. Russian.
PubMed 23268211Gurin AN, Komlev VS, Fadeeva IV, Barinov SM. [Calcium phosphate bone cements. Application in oral and maxillofacial surgery]. Stomatologiia (Mosk). 2011;90(5):64-72. No abstract available. Russian.
PubMed 22332385Gurin AN, Komlev VS, Fadeeva IV, Barinov SM. [Octacalcium phosphate--precursor of biomineralization, novel bone scaffold]. Stomatologiia (Mosk). 2010;89(4):57-64. Russian.
PubMed 21186653
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Octacalcium Phosphate Synthetic Bone Graft (OctoFor) and Bovine-derived Bone (Bio-Oss) for Ridge Preservation After Tooth Extraction: Open, Prospective, Non-Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT02155764
- Acronym / sponsor ID
- RP / 11-13
- Keywords
- tooth, extraction, alveolar socket, socket preservation, ridge preservation, bone graft, tricalcium phosphate, octacalcium phosphate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Collaborators
- Central Scientific Research Institute of Dentistry and Maxillo-facial Surgery, Moscow, Russia, Bionova, Skolkovo Community, Russia
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 4 Jun 2014 (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.
Return to normal life and shortening rehabilitation period of patients after surgical removal of teeth is important and urgent social problem. In this regard, higher demands for quality of care and treatment of patients, which requires the development of new approaches to the treatment of patients, the introduction of new technologies and the associated development of new materials . Serious problem of contemporary oral and maxillo-facial surgery and dentistry is augmentation of bone defects generated during the surgical treatment of diseases and injuries of the bones. The results of surgical repair of bone defects are more dependent on the course of the process of reparative osteogenesis. Long-term periods of clinical studies indicate that reparative osteogenesis in posttraumatic bone defects is slow - months and years, and in some cases no bone defects filled with bone tissue.
This project aims at addressing the preservation of bone volume in humans after tooth extraction using biomaterials with optimum performance. The practical significance of the project is to establish an effective tissue response and, thus, possible subsequent quality installation of dental implants. The proposed solution is based on the scientific development of the operative techniques, and a comparative analysis of several classes of biomaterials (xenogenic and synthetic analogs), including the use of biological precursors of bone apatite mineralization having osteoinductive (stimulating) properties.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Octacalcium phosphate | Experimental | Device: Octacalcium phosphateBone augmentation, after tooth extraction, with Octacalcium phosphate (synthetic bone graft material) in combination with resorbable collagen membrane Bio-Gide. |
| Bio-Oss | Active comparator | Device: Bio-OssBone augmentation, after tooth extraction, with Bio-Oss (bovine-derived xenograft)in combination with resorbable collagen membrane Bio-Gide |
| Tricalcium phosphate | Active comparator | Device: Tricalcium phosphateBone augmentation, after tooth extraction, with Tricalcium phosphate (synthetic bone graft material) in combination with resorbable collagen membrane Bio-Gide. |
Who may qualify
- Ages
- 17 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patient must have voluntarily signed the informed consent
- Males and females, 18 years to 75 years of age
- Patient needs single tooth extraction in mandibular or maxillary incisor or pre-molar region and would benefit from prosthetic reconstruction with a dental implant
- Patients must be committed to the study and must sign informed consent
- Patient in good general health as documented by self assessment
Key exclusion criteria (15 listed)
- Patient who has any known diseases (not including controlled diabetes mellitus), infections or recent surgical procedures within 30 days of study initiation
- Female patient who are pregnant or lactating or of child bearing potential not using acceptable methods of birth control (hormonal, barriers or abstinence
- Patient who are on chronic treatment (i.e., two weeks or more) with any medication known to affect oral status (e.g., phenytoin, dihydropyridine calcium antagonists, cyclosporine, and non-steroidal anti-inflammatory drugs) within one month of baseline visit
- Patient who knowingly has HIV or Hepatitis
- Alcoholism or chronically drug abuse causing systemic compromisation
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 |
|---|---|---|
| Octacalcium phosphateAlso: OctoForBone augmentation, after tooth extraction, with Octacalcium Phosphate (synthetic bone graft material) in combination with resorbable collagen membrane Bio-Gide. | Device | Octacalcium phosphate |
| Bio-OssBone augmentation, after tooth extraction, with Bio-Oss (bovine-derived xenograft)in combination with resorbable collagen membrane Bio-Gide | Device | Bio-Oss |
| Tricalcium phosphateAlso: TriCaforBone augmentation, after tooth extraction, with Tricalcium Phosphate (synthetic bone graft material) in combination with resorbable collagen membrane Bio-Gide. | Device | Tricalcium phosphate |
Primary outcome
The changes of bone level between baseline and 3 months post-extraction at the time of implantation
Time frame: baseline and 3 months post-extraction
A prefabricated stent will be used as an anchor point. After tooth extraction size of dehiscence of buccal bone from anchor point to the alveolar crest will be measured (baseline). Socket will be filled with biomaterial. After 3 months of healing at the time of implant placement the same stent will be used as an anchor point to measure size of dehiscence after socket preservation.
1 secondary outcome
Percent new vital bone formation
Time frame: 3 month
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 22 Apr 2019.
- Background: PubMed 23268211Gurin AN, Komlev VS, Fadeeva IV, Petrakiva NV, Varda NS. [A comparative study of bone regeneration potency of alfa and beta-tricalcium phosphate bone substitute materials]. Stomatologiia (Mosk). 2012;91(6):16-21. Russian.
- Background: PubMed 22332385Gurin AN, Komlev VS, Fadeeva IV, Barinov SM. [Calcium phosphate bone cements. Application in oral and maxillofacial surgery]. Stomatologiia (Mosk). 2011;90(5):64-72. No abstract available. Russian.
- Background: PubMed 21186653Gurin AN, Komlev VS, Fadeeva IV, Barinov SM. [Octacalcium phosphate--precursor of biomineralization, novel bone scaffold]. Stomatologiia (Mosk). 2010;89(4):57-64. Russian.
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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.
Anatoly Kulakov, Prof study director
Central Scientific Research Institute of Dentistry and Maxillo-facial Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Octacalcium phosphate, Bio-Oss and Tricalcium phosphate in people with Tooth Extraction and Atrophy of Edentulous Alveolar Ridge, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
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 15 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 22 Apr 2019. 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 Russia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The changes of bone level between baseline and 3 months post-extraction at the time of implantation (time frame: baseline and 3 months post-extraction). 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 NCT02155764, which also lists 3 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 22 Apr 2019.