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

Phase 4

• Conditions: Upper Central Incisor Edentulism
• Interventions: Device: NICE dental implant 3.2 mm; Device: ICE dental implant 4.2 mm; Device: Alpha Bio's Graft Bovine bone; Device: Alpha Bio's Graft resorbable membrane

• Registration Number: NCT02897193
• Lead Sponsor: Alpha - Bio Tec Ltd.

Brief Summary

Horizontal bone augmentation procedures are commonly used to increase bone width to allow the placement of dental implants or to improve aesthetics in deficient areas. Smaller diameter implants could be used instead in order to avoid bone augmentation procedures.

The comparison between these two solutions will be evaluated in the trial.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-09-01
• Study First Submitted QC: 2016-09-07
• Study First Posted: 2016-09-13
• Status Verified: 2019-06
• Last Update Submitted: 2019-07-14
• Last Update Posted: 2019-07-16
• Primary Completion: 2019-09
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 42

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
narrow implant	NICE dental implant 3.2 mm	patients will be installed with NICE Dental implant 3.2 mm diameter
Dental implant with bone augmentation	Alpha Bio's Graft resorbable membrane	patients will be installed with ICE Dental implant 4.2 mm diameter with Alpha-Bio's grafts horizontal bone augmentation
Dental implant with bone augmentation	Alpha Bio's Graft Bovine bone	patients will be installed with ICE Dental implant 4.2 mm diameter with Alpha-Bio's grafts horizontal bone augmentation
Dental implant with bone augmentation	ICE dental implant 4.2 mm	patients will be installed with ICE Dental implant 4.2 mm diameter with Alpha-Bio's grafts horizontal bone augmentation

Primary Outcome Measures

Name	Time	Method
bone loss	2 years	bone loss level as will be measured from the radio-graphic images

Secondary Outcome Measures

Name	Time	Method
Cumulative implant survival	2 years	Counting number of survived implants at the end of the study

Trial Locations

Locations (2)

University of Antofagasta; 🇨🇱 Antofagasta, Chile

Andrés Bello National University; 🇨🇱 Santiago, Chile