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Ridge Preservation With New Class of Osteoplastic Materials (RP)

Primary Purpose

Tooth Extraction, Atrophy of Edentulous Alveolar Ridge

Status
Completed
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
Octacalcium phosphate
Bio-Oss
Tricalcium phosphate
Sponsored by
I.M. Sechenov First Moscow State Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Extraction focused on measuring tooth, extraction, alveolar socket, socket preservation, ridge preservation, bone graft, tricalcium phosphate, octacalcium phosphate, xenograft, bio oss

Eligibility Criteria

17 Years - 85 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Cental Scientific Research Institute of Dentistry and Maxillo-facial Surgery

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Octacalcium phosphate

Bio-Oss

Tricalcium phosphate

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percent new vital bone formation
Bone core biopsy will be evaluated histologically for percent new vital bone formation at the time of implantation

Full Information

First Posted
May 29, 2014
Last Updated
April 19, 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
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1. Study Identification

Unique Protocol Identification Number
NCT02155764
Brief Title
Ridge Preservation With New Class of Osteoplastic Materials
Acronym
RP
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

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2016 (Actual)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
April 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the 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

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Octacalcium phosphate
Arm Type
Experimental
Arm Description
Bone augmentation, after tooth extraction, with Octacalcium phosphate (synthetic bone graft material) in combination with resorbable collagen membrane Bio-Gide.
Arm Title
Bio-Oss
Arm Type
Active Comparator
Arm Description
Bone augmentation, after tooth extraction, with Bio-Oss (bovine-derived xenograft)in combination with resorbable collagen membrane Bio-Gide
Arm Title
Tricalcium phosphate
Arm Type
Active Comparator
Arm Description
Bone augmentation, after tooth extraction, with Tricalcium phosphate (synthetic bone graft material) in combination with resorbable collagen membrane Bio-Gide.
Intervention Type
Device
Intervention Name(s)
Octacalcium phosphate
Other Intervention Name(s)
OctoFor
Intervention Description
Bone augmentation, after tooth extraction, with Octacalcium Phosphate (synthetic bone graft material) in combination with resorbable collagen membrane Bio-Gide.
Intervention Type
Device
Intervention Name(s)
Bio-Oss
Intervention Description
Bone augmentation, after tooth extraction, with Bio-Oss (bovine-derived xenograft)in combination with resorbable collagen membrane Bio-Gide
Intervention Type
Device
Intervention Name(s)
Tricalcium phosphate
Other Intervention Name(s)
TriCafor
Intervention Description
Bone augmentation, after tooth extraction, with Tricalcium Phosphate (synthetic bone graft material) in combination with resorbable collagen membrane Bio-Gide.
Primary Outcome Measure Information:
Title
The changes of bone level between baseline and 3 months post-extraction at the time of implantation
Description
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.
Time Frame
baseline and 3 months post-extraction
Secondary Outcome Measure Information:
Title
Percent new vital bone formation
Description
Bone core biopsy will be evaluated histologically for percent new vital bone formation at the time of implantation
Time Frame
3 month
Other Pre-specified Outcome Measures:
Title
Percent residual graft material and percent connective tissue
Description
Bone core biopsy will be evaluated histologically for percent residual bone graft material and percent connective tissue
Time Frame
3 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anatoly Kulakov, Prof
Organizational Affiliation
Central Scientific Research Institute of Dentistry and Maxillo-facial Surgery
Official's Role
Study Director
Facility Information:
Facility Name
Cental Scientific Research Institute of Dentistry and Maxillo-facial Surgery
City
Moscow
State/Province
RU
ZIP/Postal Code
119991
Country
Russian Federation

12. IPD Sharing Statement

Citations:
PubMed Identifier
23268211
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.
Results Reference
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PubMed Identifier
22332385
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.
Results Reference
background
PubMed Identifier
21186653
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.
Results Reference
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Ridge Preservation With New Class of Osteoplastic Materials

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