NCT03357068

Brief Summary

This study evaluates the effect of citric acid demineralization in autogenous bone blocks consolidation. Half of participants will receive citric acid treatment at the bone block and recipient site. Other half will receive no demineralization treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 29, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2018

Completed
Last Updated

February 27, 2023

Status Verified

February 1, 2023

Enrollment Period

1.1 years

First QC Date

November 22, 2017

Last Update Submit

February 24, 2023

Conditions

Alveolar Bone AtrophyBone Resorption

Outcome Measures

Primary Outcomes (3)

  • Clinical bone block consolidation

    Absence of fibrous tissue by clinical observation

    5 months

  • Computerized tomography images bone block consolidation

    Absence of images compatible to fibrosis in cone beam computerized tomography images

    5 months

  • Histological bone block consolidation

    Absence of fibrous tissue between bone block and recipient site in histological images.

    5 months

Secondary Outcomes (1)

  • Bone width

    5 months

Study Arms (2)

Control

ACTIVE COMPARATOR

Autogenous bone block surgery without treatment of bone surfaces.

Procedure: Control

Acid

EXPERIMENTAL

Autogenous bone block surgery with citric acid treatment of bone block and recipient site

Procedure: Acid

Interventions

ControlPROCEDURE

Control side will receive only perforations on recipient site, which is the conventional technique for bone blocks graft.

Control
AcidPROCEDURE

Test side will receive treatment with citric acid (10%) for 30s at bone block surface and recipient site

Acid

Eligibility Criteria

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

You may qualify if:

  • Presence of atrophic anterior maxilla (width 1.5 to 4 mm)
  • Absence of active periodontal disease.
  • Enough bone width on donor sites (oblique line or ment)

You may not qualify if:

  • Systemic disease that impede surgical procedure as blood diseases, endocrine diseases, impaired coagulation
  • Smokers
  • Pregnant women
  • Patients receiving radiotherapy or chemotherapy
  • Patients using bisphosphonates

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bauru School of Dentistry

Bauru, São Paulo, 17012-901, Brazil

Location

Related Publications (1)

  • Rezende ML, Consolaro A, Sant'Ana AC, Damante CA, Greghi SL, Passanezi E. Demineralization of the contacting surfaces in autologous onlay bone grafts improves bone formation and bone consolidation. J Periodontol. 2014 May;85(5):e121-9. doi: 10.1902/jop.2013.130298. Epub 2013 Oct 30.

    PMID: 24171500BACKGROUND

MeSH Terms

Conditions

Alveolar Bone LossBone Resorption

Interventions

Acids

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Inorganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Split mouth design - one side of mouth is test group, other side is control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

November 22, 2017

First Posted

November 29, 2017

Study Start

July 1, 2017

Primary Completion

July 30, 2018

Study Completion

December 22, 2018

Last Updated

February 27, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)