NCT02903667

Brief Summary

An open, prospective, randomized, multicenter study focused on the ridge diminution in case of grafting of fresh extraction sockets with Bio-Oss Collagen, Bio-Gide (Geistlich Pharma, Wolhusen, Switzerland), placing Dentsply implants (Astra Tech System).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2015

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

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

March 1, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 1, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 16, 2016

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

8.5 years

First QC Date

September 1, 2016

Last Update Submit

November 16, 2025

Conditions

Alveolar Ridge TraumaBone Resorption

Keywords

bone graftingimplantologyoral surgery

Outcome Measures

Primary Outcomes (1)

  • Cone Beam Computerized Tomographic (CBCT) examination at the center of each extraction socket, between the sockets, at the septum next to adjacent teeth.

    Measurements of alveolar ridge dimensional changes in the first 6 months of healing

    Up to 24 weeks

Secondary Outcomes (1)

  • Standard intraoral radiograph of each experimental socket and inter-dental bone

    3 years follow up

Study Arms (2)

bone grafting

EXPERIMENTAL

The possibility of counteracting unfavourable ridge modelling after multiple tooth extractions by placing bone grafting material in the fresh extraction sites.

Device: Bone grafting

natural healing

SHAM COMPARATOR

ridge modelling after multiple tooth extractions.

Device: Bone grafting

Interventions

Bone graftingDEVICE
bone graftingnatural healing

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • a marginal dehiscence defect of any of the facial bone walls of 3 mm
  • no facial fenestration present in the apical of the marginal bone crest

You may not qualify if:

  • untreated rampant caries and uncontrolled periodontal disease
  • uncontrolled diabetes or any other systemic or local disease or condition that would compromise post-operative healing
  • unable or unwilling to return for follow-up or unlikely to be able to comply with study procedures according to investigators judgement.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Franci Institute

Padua, 35121, Italy

Location

MeSH Terms

Conditions

Bone Resorption

Interventions

Bone Transplantation

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Tissue TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsOrthopedic ProceduresSurgical Procedures, OperativeTransplantation

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2016

First Posted

September 16, 2016

Study Start

March 1, 2015

Primary Completion

September 1, 2023

Study Completion

September 1, 2023

Last Updated

November 19, 2025

Record last verified: 2025-11

Locations

IT(1)