Ridge Preservation With New Class of Osteoplastic Materials

Tooth Extraction Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02155764
• Other study ID #: 11-13
• Secondary ID: 11-13
• Status: Completed
• Phase: Phase 2
• Start date: September 1, 2016
• Est. completion date: April 1, 2019

Study information

• Verified date: April 2019
• Source: I.M. Sechenov First Moscow State Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 1, 2019
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Atrophy
• Atrophy of Edentulous Alveolar Ridge
• Tooth Extraction

Intervention

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

Locations

Country	Name	City	State
Russian Federation	Cental Scientific Research Institute of Dentistry and Maxillo-facial Surgery	Moscow	RU

Sponsors (3)

Lead Sponsor	Collaborator
I.M. Sechenov First Moscow State Medical University	Bionova, Skolkovo Community, Russia, Central Scientific Research Institute of Dentistry and Maxillo-facial Surgery, Moscow, Russia

Country where clinical trial is conducted

Russian Federation, 

References & Publications (3)

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. Review. Russian. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percent residual graft material and percent connective tissue	Bone core biopsy will be evaluated histologically for percent residual bone graft material and percent connective tissue	3 month
Primary	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	Percent new vital bone formation	Bone core biopsy will be evaluated histologically for percent new vital bone formation at the time of implantation	3 month