Tooth Roots for Lateral Alveolar Ridge Augmentation

December 16, 2020 updated by: Igor Smojver, St. Catherine Specialty Hospital

Autogenous Tooth Roots for Lateral Alveolar Ridge Augmentation and Staged Implant Placement

A deficient alveolar ridge segment in prepara¬tion for implant placement can be regenerated by several techniques. The type of graft material for each patient depends on many factors such as the anatomy, the morphology of the bone defect, type of prosthodontic rehabilitation and patient or clinician preferences. Bone graft material should have three properties that made it ideal: a) osteoconduction, it provides scaffolds for bone regeneration; b) osteoinduction, it promotes the recruitment of bone-forming cells and formation of bone and c) osteogenesis, induction of cells in the graft to promote regeneration of the bone.

Despite of the development of different types of graft material, autogenous bone is still the gold standard for bone augmentation because it exhibits these three mentioned properties. Although it has many advantages, autologous bone has some disadvantages such as high resorption rate up to 50 %, limited source and donor site morbidity. Allografts, xenografts and alloplastic bone graft are materials that are used in everyday practice and over long period, but their disadvantages are numerous in comparison with autologous bone. Allografts can be carrier of some disease and show lack of osteoproliferation, while alloplasts and xenografts show only osteoconduction. According to these facts, it is obvious that there is a need for development an alternative graft material that will surpass these disadvantages.The reconstruction of deficient alveolar ridge defect by the lateral bone augmentation prior to the dental implant placement is predictable and commonly used method. Except animal studies, recent clinical studies showed that there is no difference in the osseointegration of titanium implants in deficient alveolar ridges reconstructed with autogenous cortical bone blocks or autogenous teeth.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Zagreb, Croatia, 10000
        • St. Catherine Specialty Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age 18 to 60 years
  • candidate for lateral ridge augmentation
  • insufficient bone ridge width at the recipient site for implant placement
  • sufficient bone height at the recipient site for implant placement and (e)
  • healthy oral mucosa
  • at least 2 mm keratinized tissue

Exclusion Criteria:

  • general contraindications for dental and/or surgical treatments
  • inflammatory and autoimmune disease of the oral cavity,
  • uncontrolled diabetes (HbA1c > 7%)
  • history of chemotherapy or radiotherapy within the past five years,
  • previous immunosuppressant, bisphosphonate or high- dose corticosteroid therapy
  • smokers
  • pregnant or lactating women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: bone defect surgery
augmentation on insufficient alveolar ridges with autologous teeth will be performed (wisdom tooth or periodontally compromised tooth)
Procedure: tooth root augmentation
Autogenous tooth roots for lateral alveolar ridge augmentation and staged implant placement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary endpoint was defined as the clinical width (CW) of the alveolar ridge
Time Frame: 6 months

The primary endpoint was defined as the clinical width (CW) of the alveolar ridge being sufficient for the placement of an adequately dimensioned dental implant without the need for a secondary grafting at 6 months after surgery in either group. CW was assessed before (CWa) and after (CWb) augmentation healing period of 6 months in cone-beam computed tomography (CBCT) scans.

Measurements were performed to the nearest 0.5mm below the crest using a CBCT.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Periimplant tissue stability of augmented sites after prosthetic rehabilitation
Time Frame: 12 months
Usage of periimplant tissue parameters for assessing the conditions around implants placed in augmented sites using pink esthetic score (PES) that evaluates the esthetic outcome of soft tissue around implant-supported single crowns by awarding seven points for the mesial and distal papilla, soft-tissue level, soft-tissue contour, soft-tissue color, soft-tissue texture, and alveolar process deficiency.
12 months
gain in ridge width (CWg)
Time Frame: 6 months
CWg (mm) = CWb ( ridge after surgery in mm)- CWa ( ridge before surgery in mm)
6 months
soft tissue dehiscences
Time Frame: 6 months
yes/no for secondary wound healing
6 months
wound infections
Time Frame: 6 months
monitoring whether there is an increased incidence of inflammatory conditions after the specified procedure
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Catherine Specialty Hospital

Investigators

  • Study Director: Dragana Gabrić, PhD, School of Dental Medicine Zagreb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2019

Primary Completion (Actual)

September 1, 2020

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

December 8, 2020

First Submitted That Met QC Criteria

December 16, 2020

First Posted (Actual)

December 22, 2020

Study Record Updates

Last Update Posted (Actual)

December 22, 2020

Last Update Submitted That Met QC Criteria

December 16, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16041985

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

individual participant data will be available all time

IPD Sharing Time Frame

12 moths

IPD Sharing Access Criteria

only researchers

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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