---
title: Central Incisors Narrow Implants in Alternative to Bone Augmentation With 4.2 mm Implants .
nct_id: NCT02897193
overall_status: UNKNOWN
phase: PHASE4
sponsor: Alpha - Bio Tec Ltd.
study_type: INTERVENTIONAL
primary_condition: Upper Central Incisor Edentulism
countries: Chile
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02897193.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02897193"
ct_last_update_post_date: 2019-07-16
last_seen_at: "2026-05-12T07:26:31.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Central Incisors Narrow Implants in Alternative to Bone Augmentation With 4.2 mm Implants .

**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

**NCT ID:** [NCT02897193](https://clinicaltrials.gov/study/NCT02897193)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 42
- **Lead Sponsor:** Alpha - Bio Tec Ltd.
- **Conditions:** Upper Central Incisor Edentulism
- **Start Date:** 2016-08
- **Completion Date:** 2019-12
- **CT.gov Last Update:** 2019-07-16

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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).
```

## Arms

- **Dental implant with bone augmentation** (ACTIVE_COMPARATOR) — patients will be installed with ICE Dental implant 4.2 mm diameter with Alpha-Bio's grafts horizontal bone augmentation
- **narrow implant** (EXPERIMENTAL) — patients will be installed with NICE Dental implant 3.2 mm diameter

## Interventions

- **ICE dental implant 4.2 mm** (DEVICE) — ICE dental implant 4.2 mm diameter
- **NICE dental implant 3.2 mm** (DEVICE) — NICE dental implant 4.2 mm diameter
- **Alpha Bio's Graft Bovine bone** (DEVICE) — Alpha Bio's Graft Bovine Bone
- **Alpha Bio's Graft resorbable membrane** (DEVICE) — Alpha Bio's Graft resorbable collagen membrane

## Primary Outcomes

- **bone loss** _(time frame: 2 years)_ — bone loss level as will be measured from the radio-graphic images

## Secondary Outcomes

- **Cumulative implant survival** _(time frame: 2 years)_

## Locations (2)

- University of Antofagasta, Antofagasta, Chile
- Andrés Bello National University, Santiago, Chile

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university of antofagasta|antofagasta||chile` — added _(2026-05-12)_
- `locations.andrés bello national university|santiago||chile` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02897193.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02897193*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*