Clinical trial NCT02155764: Ridge Preservation With New Class of Osteoplastic Materials
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tooth Extraction
Atrophy of Edentulous Alveolar Ridge
Keywords: tooth
extraction
alveolar socket
socket preservation
ridge preservation
bone graft
tricalcium phosphate
octacalcium phosphate
xenograft
bio oss
Lead sponsor: I.M. Sechenov First Moscow State Medical University
Sponsor class: OTHER
Collaborators: name: Central Scientific Research Institute of Dentistry and Maxillo-facial Surgery, Moscow, Russia
name: Bionova, Skolkovo Community, Russia
First posted: 2014-06-04
Enrollment: 60
Sex: ALL
Minimum age (years): 17
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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
* 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)

Primary outcomes:
measure: The changes of bone level between baseline and 3 months post-extraction at the time of implantation
timeFrame: baseline and 3 months post-extraction
Secondary outcomes:
measure: Percent new vital bone formation
timeFrame: 3 month
Other outcomes:
measure: Percent residual graft material and percent connective tissue
timeFrame: 3 month
Locations:
city: Moscow
country: Russian Federation
facility: Cental Scientific Research Institute of Dentistry and Maxillo-facial Surgery
state: RU
Study officials:
affiliation: Central Scientific Research Institute of Dentistry and Maxillo-facial Surgery
name: Anatoly Kulakov, Prof
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Gurin 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.
citation: Gurin AN, Komlev VS, Fadeeva IV, Barinov SM. [Octacalcium phosphate--precursor of biomineralization, novel bone scaffold]. Stomatologiia (Mosk). 2010;89(4):57-64. Russian.