NCT05593198

Brief Summary

The purpose of this study is to analyze the volumetric gain and stability of the newly formed bone tissue comparing guided bone regeneration with block graft.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

September 5, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 25, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2023

Completed
Last Updated

August 29, 2023

Status Verified

October 1, 2022

Enrollment Period

8 months

First QC Date

September 5, 2022

Last Update Submit

August 28, 2023

Conditions

Atrophy; Bone

Keywords

Bone Regeneration

Outcome Measures

Primary Outcomes (1)

  • Bone volume

    the bone volume will be analyzed with the Cone Beam Computed Tomography scan

    6 Months follow up

Secondary Outcomes (3)

  • Periodontal parameters

    6 Months follow up

  • Wound healing

    2 weeks follow up

  • Histological analysis

    6 Months follow up

Study Arms (2)

Guided bone regeneration

ACTIVE COMPARATOR

Patients will be treated with guided bone regeneration.

Procedure: Guided bone regeneration

Bone block

EXPERIMENTAL

Patients will be treated with bone blocks using the Khoury technique.

Procedure: Khoury technique

Interventions

Khoury techniquePROCEDURE

the bone block will be used following the principles of the Khoury technique to augment the bone volume.

Bone block
Guided bone regenerationPROCEDURE

the membrane and the bone granules will be used to perform the guided bone regeneration technique.

Guided bone regeneration

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients in need of an implant-supported rehabilitation
  • Patients requiring bone regeneration
  • Healthy patients
  • Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) ≤ 15%
  • Sufficient mesiodistal and interocclusal space
  • At least 6 months of follow-up

You may not qualify if:

  • An American Society of Anesthesiologists physical status classification ≥ III
  • General contraindications for surgical treatment or implant placement
  • Untreated periodontitis
  • Smoking
  • Excessive alcohol consumption
  • Any drug or medication known to affect oral status and bone turnover or contraindicate surgical treatment
  • No residual keratinized tissue at the experimental area
  • Unwillingness to return for follow-up examinations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Gemelli

Rome, Italy

Location

MeSH Terms

Conditions

Atrophy

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Antonio D'Addona, DDS

    Fondazione Policlinico Gemelli

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2022

First Posted

October 25, 2022

Study Start

November 1, 2022

Primary Completion

July 1, 2023

Study Completion

July 2, 2023

Last Updated

August 29, 2023

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)