NCT07401238

Brief Summary

the goal of the study was the evaluation of the clinical and histological performance of delayed inserted implants in augmented sites with a shaped solid graft inserted in an originally narrow alveolar edentulous ridge.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2016

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2016

Completed
9.1 years until next milestone

First Submitted

Initial submission to the registry

February 3, 2026

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 10, 2026

Completed
Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

9.1 years

First QC Date

February 3, 2026

Last Update Submit

February 3, 2026

Conditions

Keywords

implantalveolar ridge expansiongraft

Outcome Measures

Primary Outcomes (1)

  • postoperative surgical width

    radiologically measured alveolar expansion

    5 months

Secondary Outcomes (1)

  • new bone formation

    5 months later than surgery

Study Arms (1)

narrow ridge

EXPERIMENTAL

width comprised between 3 and 5 mm

Procedure: Alveolar Ridge Reconstruction

Interventions

wedge shaped xenograft inserted in splitted alveolar crest

Also known as: split crest
narrow ridge

Eligibility Criteria

AgeUp to 99 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \. Patients with single mandibular or maxillary intercalated edentulism (1 implant) who require implant rehabilitation with conventional loading 2. The edentulous site width should be comprised between 3 and 5mm for the first 3mm of height 3. Presence of visible spongious bone in CBCT cross-sections 4. The edentulous site must present at least 4mm wide band of keratinized tissue 5. Plaque index \< 20%, Bleeding index \< 25% 6. Medical condition of the enrolled patients should be within ASA 2 score 7. Only no smokers, light smokers (\< 10 per day) or electronic smokers will be accepted

You may not qualify if:

  • \. Head and neck RT in the previous 5 years 2. Previous or actual antiresorptive therapy 3. Chronic corticosteroid therapy 4. Active periodontal disease 5. Pregnancy or breastfeeding 6. Abuse of alcohol or drugs 7. Incapability of understanding the purposes of the study (e.g. mental deficit)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Li X, Xu P, Xu X, Liu S. The application of a delayed expansion technique for horizontal alveolar ridge augmentation in dental implantation. Int J Oral Maxillofac Surg. 2017 Nov;46(11):1451-1457. doi: 10.1016/j.ijom.2017.05.025. Epub 2017 Jun 26.

    PMID: 28663017BACKGROUND

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: case series
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof

Study Record Dates

First Submitted

February 3, 2026

First Posted

February 10, 2026

Study Start

December 15, 2016

Primary Completion

February 3, 2026

Study Completion

February 3, 2026

Last Updated

February 10, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share