Randomized Clinical Trial, conventional treatment-controlled, studying the efficacy of Plasma Rich in Growth Factor (PRGF®) in alveolar ridge preservation after simple exodontia in the anterior region of maxilla.

Phase 1

• Conditions: Alveolar ridge preservation after exodontia of uniradiculate dental pience in the anterior region of maxilla; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Dentistry [E06]

• Registration Number: EUCTR2019-001167-75-ES
• Lead Sponsor: BTI I MAS D

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-11
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 62

Inclusion Criteria

- Subjects of both sexes with an age greater than or equal to 18 years.
- Clinical indication for a simple exodontia of a uniradicular tooth in the superior maxilla
- Availability to follow-up during the treatment period
- Subjects with non-active periodontal disease.
- Buccal dehiscence < than 25% in the vestibular table
- Signing the informed content
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 56
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

Presence of an active infection
- Loss of any plate of the socket
- Severe inflammation in the area of the exodontia previous to the intervention
- Suffer any severe hematologic disease o disorder
- Have received radiotherapy, chemotherapy or immunosuppressive treatments, systemic corticosteroids and/or anticoagulants the 30 days prior to inclusion
- Regular treatment with AINES or other antiinflammatory drugs
- Previous history of chronic hepatitis or heatic cirrhosis
- Uncontrolled diabetes mellitus (Glycosylated hemoglobin higher than 9%)
- Subjects submitted to hemodyalisis
- Presence of malignant tumour, haemangiomas or angioma in the exodontia region.
- Previous history of ischemic cardiopathy in the last year.
- Pregnancy or womens in childbearing age who do not take contraception measures.
- Nursing womens
- Metabolic bone disease
- Ongoing treatment with biphosphonates both through oral or intravenous administration
- Smoking habits (> 10 cigarrettes/day)
- In general, any disability to participate in the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified