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

Upper Central Incisor Edentulism Clinical Trial

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02897193
• Other study ID #: ABT-ME-130815
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: August 2016
• Est. completion date: December 2019

Study information

• Verified date: June 2019
• Source: Alpha - Bio Tec Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 42
• Est. completion date: December 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Upper Central Incisor Edentulism

Intervention

Device:
• ICE dental implant 4.2 mm
ICE dental implant 4.2 mm diameter
• NICE dental implant 3.2 mm
NICE dental implant 4.2 mm diameter
• Alpha Bio's Graft Bovine bone
Alpha Bio's Graft Bovine Bone
• Alpha Bio's Graft resorbable membrane
Alpha Bio's Graft resorbable collagen membrane

Locations

Country	Name	City	State
Chile	University of Antofagasta	Antofagasta
Chile	Andrés Bello National University	Santiago

Sponsors (1)

Lead Sponsor	Collaborator
Alpha - Bio Tec Ltd.

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bone loss	bone loss level as will be measured from the radio-graphic images	2 years
Secondary	Cumulative implant survival	Counting number of survived implants at the end of the study	2 years

External Links

•   sponsor site