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NCT Number: NCT03357068

Effect of Citric Acid Demineralization on Autogenous Bone Blocks Consolidation in Humans

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.

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Key information

Conditions

Alveolar Bone Atrophy Alveolar Bone Loss Bone Diseases Bone Resorption Mouth Diseases Musculoskeletal Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bauru School of Dentistry

Bauru, São Paulo, 17012-901, Brazil

About this study

Autogenous bone grafts are indicated in areas where there is not enough bone height and/or width for implant installation. Treatment of bone surfaces with citric acid, promote a slight demineralization on surface that mimic natural processes of bone demineralization by osteoclasts. Thus, this treatment could accelerate the process of autogenous bone block consolidation to its recipient site.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

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

Treatment and study plan

Control

Procedure

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

Acid

Procedure

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

Primary outcomes

  1. Clinical bone block consolidation

    Time frame: 5 months

    Absence of fibrous tissue by clinical observation

  2. Computerized tomography images bone block consolidation

    Time frame: 5 months

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

  3. Histological bone block consolidation

    Time frame: 5 months

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

Secondary outcomes

  1. Bone width

    Time frame: 5 months

    Measurement of bone width in mm on cone beam computerized tomography. Ideal if >6 mm.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

Effect of Citric Acid Demineralization on Autogenous Bone Blocks Consolidation in Humans: Qualitative, Quantitative and Immunohistochemical Analysis

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 29, 2017
Registry last updated
Feb 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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