Central Incisors Narrow Implants in Alternative to Bone Augmentation With 4.2 mm Implants .

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02897193
• Date of registration: 01/09/2016
• Prospective Registration: No
• Primary sponsor: Alpha - Bio Tec Ltd.
• Public title: Central Incisors Narrow Implants in Alternative to Bone Augmentation With 4.2 mm Implants .
• Scientific title: 3.2 mm Diameter Implants and Soft Tissue Grafts in Alternative to Horizontal Bone Augmentation for Placing 4.2 mm Diameter Implants at Central Incisors. A Multicenter Randomised Controlled Trial
• Date of first enrolment: August 2016
• Target sample size: 42
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02897193
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Chile

Key inclusion & exclusion criteria

Inclusion Criteria:

- Upper central incisor edentulism

- bone width between 3.5-4.5 mm

- requirement of only one implant supported crown

- patient is willing to sign an informed consent

Exclusion Criteria:

- General contraindications to implant surgery.

- Immunosuppressed or immunocompromised patients

- Patients irradiated in the head and neck area.

- Patients with poor oral hygiene and motivation.

- Uncontrolled diabetes.

- Pregnancy or lactation.

- Addiction to alcohol or drugs.

- Untreated periodontal disease.

- Treated or under treatment with intravenous amino-biphosphonates.

- Poor oral hygiene and motivation.

- Psychiatric problems and/or unrealistic expectations.

- Acute infection (abscess) or suppuration in the area intended for implant placement.

- Patients referred only for implant placement if cannot be followed at the treatment
centre.

- Patient unable to attend the follow-up controls for 3 years after implant loading.

- Patient included in other studies, if this protocol cannot be properly followed.

- Immediate post-extractive sites (to be eligible at least 3 months must have passed
since extraction).



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Upper Central Incisor Edentulism

Intervention(s)

Device: ICE dental implant 4.2 mm

Device: NICE dental implant 3.2 mm

Device: Alpha Bio's Graft Bovine bone

Device: Alpha Bio's Graft resorbable membrane

Primary Outcome(s)

bone loss [Time Frame: 2 years]

Secondary Outcome(s)

Cumulative implant survival [Time Frame: 2 years]

Secondary ID(s)

ABT-ME-130815

Source(s) of Monetary Support

Please refer to primary and secondary sponsors