Ridge Preservation With New Class of Osteoplastic Materials

NCT02155764 | Completed Phase 2

• 1 other identifier: 11-13
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline and 3 months post-extraction

Secondary Outcomes (1)

• Percent new vital bone formation

  3 month

Other Outcomes (1)

• Percent residual graft material and percent connective tissue

  3 month

Study Arms (3)

Octacalcium phosphate

EXPERIMENTAL

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

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

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.

Device: Tricalcium phosphate

Interventions

Octacalcium phosphate DEVICE

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

Also known as: OctoFor

Octacalcium phosphate

Bio-Oss DEVICE

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

Bio-Oss

Tricalcium phosphate DEVICE

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

Also known as: TriCafor

Tricalcium phosphate

Eligibility Criteria

• Age: 17 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead
• Central Scientific Research Institute of Dentistry and Maxillo-facial Surgery, Moscow, Russia: collaborator
• Bionova, Skolkovo Community, Russia: collaborator

Study Sites (1)

Cental Scientific Research Institute of Dentistry and Maxillo-facial Surgery

Moscow, RU, 119991, Russia

Location

Related Publications (3)

• 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.

  PMID: 23268211 BACKGROUND

• 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.

  PMID: 22332385 BACKGROUND

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

  PMID: 21186653 BACKGROUND

Study Officials

• Anatoly Kulakov, Prof

  Central Scientific Research Institute of Dentistry and Maxillo-facial Surgery

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant, PhD

Study Record Dates

• First Submitted: May 29, 2014
• First Posted: June 4, 2014
• Study Start: September 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: April 1, 2019
• Last Updated: April 22, 2019

Record last verified: 2019-04

Locations

RU (1)