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Ridge Preservation With New Class of Osteoplastic Materials (RP)

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ClinicalTrials.gov Identifier: NCT02155764
Recruitment Status : Not yet recruiting
First Posted : June 4, 2014
Last Update Posted : March 13, 2018
Sponsor:
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

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 Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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




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



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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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02155764


Contacts
Contact: Alex Gurin, PhD 0079165884088 gurin.alex@gmail.com
Contact: Vladimir Komlev, Prof vskomlev@gmail.com

Locations
Russian Federation
Cental Scientific Research Institute of Dentistry and Maxillo-facial Surgery Not yet recruiting
Moscow, RU, Russian Federation, 119991
Contact: Alex Gurin, PhD    0079165884088    gurin.alex@gmail.com   
Principal Investigator: Alex Gurin, PhD         
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

Publications:
Responsible Party: Alex Gurin, Teaching Assistant, PhD, I.M. Sechenov First Moscow State Medical University
ClinicalTrials.gov Identifier: NCT02155764     History of Changes
Other Study ID Numbers: 11-13
11-13 ( Other Identifier: The I.M. Sechenov Moscow Medical Academy )
First Posted: June 4, 2014    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018

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