Ridge Preservation With New Class of Osteoplastic Materials (RP)

• ClinicalTrials.gov Identifier: NCT02155764
• Recruitment Status: Completed
• First Posted: June 4, 2014
• Last Update Posted: April 22, 2019
• Sponsor: I.M. Sechenov First Moscow State Medical University
• Collaborators: Central Scientific Research Institute of Dentistry and Maxillo-facial Surgery, Moscow, Russia; Bionova, Skolkovo Community, Russia
• Information provided by (Responsible Party): Alex Gurin, I.M. Sechenov First Moscow State Medical University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Tooth Extraction; Atrophy of Edentulous Alveolar Ridge	Device: Octacalcium phosphate; Device: Bio-Oss; Device: Tricalcium phosphate	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: September 1, 2016
• Actual Primary Completion Date: December 1, 2018
• Actual Study Completion Date: April 1, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Octacalcium phosphate; Bone augmentation, after tooth extraction, with Octacalcium phosphate (synthetic bone graft material) in combination with resorbable collagen membrane Bio-Gide.	Device: Octacalcium phosphate; Bone augmentation, after tooth extraction, with Octacalcium Phosphate (synthetic bone graft material) in combination with resorbable collagen membrane Bio-Gide.; Other Name: OctoFor
Active Comparator: Bio-Oss; Bone augmentation, after tooth extraction, with Bio-Oss (bovine-derived xenograft)in combination with resorbable collagen membrane Bio-Gide	Device: Bio-Oss; Bone augmentation, after tooth extraction, with Bio-Oss (bovine-derived xenograft)in combination with resorbable collagen membrane Bio-Gide
Active Comparator: Tricalcium phosphate; Bone augmentation, after tooth extraction, with Tricalcium phosphate (synthetic bone graft material) in combination with resorbable collagen membrane Bio-Gide.	Device: Tricalcium phosphate; Bone augmentation, after tooth extraction, with Tricalcium Phosphate (synthetic bone graft material) in combination with resorbable collagen membrane Bio-Gide.; Other Name: TriCafor

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. Percent new vital bone formation [ Time Frame: 3 month ]
   Bone core biopsy will be evaluated histologically for percent new vital bone formation at the time of implantation

Other Outcome Measures:

1. Percent residual graft material and percent connective tissue [ Time Frame: 3 month ]
   Bone core biopsy will be evaluated histologically for percent residual bone graft material and percent connective tissue

Eligibility Criteria

• Ages Eligible for Study: 17 Years to 85 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

Russian Federation

Cental Scientific Research Institute of Dentistry and Maxillo-facial Surgery

Moscow, RU, Russian Federation, 119991

Sponsors and Collaborators

I.M. Sechenov First Moscow State Medical University

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

Bionova, Skolkovo Community, Russia

Investigators

• Study Director: Anatoly Kulakov, Prof; Central Scientific Research Institute of Dentistry and Maxillo-facial Surgery

More Information

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.

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.

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

• Responsible Party: Alex Gurin, Teaching Assistant, PhD, I.M. Sechenov First Moscow State Medical University
• ClinicalTrials.gov Identifier: NCT02155764
• Other Study ID Numbers: 11-13; 11-13 ( Other Identifier: The I.M. Sechenov Moscow Medical Academy )
• First Posted: June 4, 2014
• Last Update Posted: April 22, 2019
• Last Verified: April 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Alex Gurin, I.M. Sechenov First Moscow State Medical University:

tooth; extraction; alveolar socket; socket preservation; ridge preservation; bone graft; tricalcium phosphate; octacalcium phosphate; xenograft; bio oss

Additional relevant MeSH terms:

Atrophy; Pathological Conditions, Anatomical