Guided Bone Regeneration Using Synthetic Membrane

RegeneCure

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Jaw, Edentulous, Partially; Jaw, Edentulous

Treatments: Device: Regenecure AMCA GBR Dental Membrane; Device: Geistlich Bio-Gide® collagen membrane

Study type: Interventional

Funder types: Industry

Identifiers

NCT01654627

RGD001

Details and patient eligibility

About

The purpose of this study is to examine the safety and usefulness of the Regenecure guided bone regeneration membrane for stimulating bone growth in patients that don't have enough bone for dental implant placement. The study will include 16 patients in each group, 20 non-smokers and 12 smokers, a total of 32 patients will participate in the study.

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject must have voluntarily signed the informed consent form before any study related action
• Age: 18 to 65 with missing teeth, seeking for implant therapy.
• Men/Women
• In good systemic health
• Present with no contra indication against oral surgical interventions
• Single/ multiple tooth gap - have at least one missing tooth in the mandible or maxilla, requiring one or more dental implants.
• The tooth at the implant site(s) must have been extracted or lost at least 6 weeks before the date of implantation.
• Bone defect(s) must be present with a lateral dimension greater than or equal to 5 mm or less.
• Full mouth plaque score (FMPI) lower or equal than 25%
• Patients must be committed to the study

Exclusion criteria

• Medical conditions requiring prolonged use of steroids
• Use of Bisphosphonate intravenously
• Current pregnancy or breastfeeding women
• Alcoholism or chronically drug abuse
• Immunocompromised patients
• Uncontrolled Diabetes
• Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unreliability.
• Untreated inflammation
• Mucosal diseases or oral lesions
• History of local irradiation therapy
• Persistent intraoral infection
• Patients with bad oral hygiene or unmotivated for normal home care.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

32 participants in 2 patient groups

Regenecure AMCA GBR Dental membrane

Experimental group

Description:

16 patients will undergo the guided bone regeneration procedure using the Regenecure AMCA Membrane

Treatment:

Device: Regenecure AMCA GBR Dental Membrane

Collagen membrane

Active Comparator group

Description:

16 patients will undergo the guided bone regeneration procedure using a commercially available collagen membrane

Treatment:

Device: Geistlich Bio-Gide® collagen membrane