Ridge Preservation With New Class of Osteoplastic Materials

NCT ID: NCT02155764

Last Updated: 2019-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-01
• Study Completion Date: 2019-04-01

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.

Conditions

Tooth Extraction; Atrophy of Edentulous Alveolar Ridge

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Octacalcium phosphate

Bone augmentation, after tooth extraction, with Octacalcium phosphate (synthetic bone graft material) in combination with resorbable collagen membrane Bio-Gide.

Group Type: EXPERIMENTAL

Octacalcium phosphate

Intervention Type: DEVICE

Bone augmentation, after tooth extraction, with Octacalcium Phosphate (synthetic bone graft material) in combination with resorbable collagen membrane Bio-Gide.

Bio-Oss

Bone augmentation, after tooth extraction, with Bio-Oss (bovine-derived xenograft)in combination with resorbable collagen membrane Bio-Gide

Group Type: ACTIVE_COMPARATOR

Bio-Oss

Intervention Type: DEVICE

Bone augmentation, after tooth extraction, with Bio-Oss (bovine-derived xenograft)in combination with resorbable collagen membrane Bio-Gide

Tricalcium phosphate

Bone augmentation, after tooth extraction, with Tricalcium phosphate (synthetic bone graft material) in combination with resorbable collagen membrane Bio-Gide.

Group Type: ACTIVE_COMPARATOR

Tricalcium phosphate

Intervention Type: DEVICE

Bone augmentation, after tooth extraction, with Tricalcium Phosphate (synthetic bone graft material) in combination with resorbable collagen membrane Bio-Gide.

Interventions

Octacalcium phosphate

Bone augmentation, after tooth extraction, with Octacalcium Phosphate (synthetic bone graft material) in combination with resorbable collagen membrane Bio-Gide.

Intervention Type: DEVICE

Bio-Oss

Bone augmentation, after tooth extraction, with Bio-Oss (bovine-derived xenograft)in combination with resorbable collagen membrane Bio-Gide

Intervention Type: DEVICE

Tricalcium phosphate

Bone augmentation, after tooth extraction, with Tricalcium Phosphate (synthetic bone graft material) in combination with resorbable collagen membrane Bio-Gide.

Intervention Type: DEVICE

Other Intervention Names

OctoFor; TriCafor

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

• 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).

• 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)

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Central Scientific Research Institute of Dentistry and Maxillo-facial Surgery, Moscow, Russia

UNKNOWN

Sponsor Role: collaborator

Bionova, Skolkovo Community, Russia

UNKNOWN

Sponsor Role: collaborator

I.M. Sechenov First Moscow State Medical University

OTHER

Sponsor Role: lead

Responsible Party

Alex Gurin

Teaching Assistant, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anatoly Kulakov, Prof

Role: STUDY_DIRECTOR

Central Scientific Research Institute of Dentistry and Maxillo-facial Surgery

Locations

Cental Scientific Research Institute of Dentistry and Maxillo-facial Surgery

Moscow, RU, Russia

Countries

Russia

References

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.

Reference Type: BACKGROUND

PMID: 23268211 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22332385 (View on PubMed)

Gurin AN, Komlev VS, Fadeeva IV, Barinov SM. [Octacalcium phosphate--precursor of biomineralization, novel bone scaffold]. Stomatologiia (Mosk). 2010;89(4):57-64. Russian.

Reference Type: BACKGROUND

PMID: 21186653 (View on PubMed)

Other Identifiers

11-13

Identifier Type: OTHER

Identifier Source: secondary_id

11-13

Identifier Type: -

Identifier Source: org_study_id