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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02897193

Enrollment

Registered

2016-09-13

Start date

2016-08-31

Completion date

2019-12-31

Last updated

2019-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Upper Central Incisor Edentulism

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.

Interventions

DEVICEICE dental implant 4.2 mm

ICE dental implant 4.2 mm diameter

DEVICENICE dental implant 3.2 mm

NICE dental implant 4.2 mm diameter

DEVICEAlpha Bio's Graft Bovine bone

Alpha Bio's Graft Bovine Bone

DEVICEAlpha Bio's Graft resorbable membrane

Alpha Bio's Graft resorbable collagen membrane

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
bone loss	2 years	bone loss level as will be measured from the radio-graphic images

Secondary

Measure	Time frame	Description
Cumulative implant survival	2 years	Counting number of survived implants at the end of the study

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026