NCT04393714

Brief Summary

The reduction in alveolar bone dimensions is an inevitable outcome after tooth extraction due to the healing events that results in bone modeling/remodeling. Alveolar ridge preservation is a successful approach that aids in reducing these changes greatly. Various techniques have been employed to achieve that outcome utilizing bone grafts and/or membrane. Dentin graft is a promising type that can overcome many of the limitations facing mainstream grafts. Autogenous source serve the advantage of providing graft with no cross-infection risk or immunogenicity. Moreover, the unique structure of dentin makes it suitable for osteoinduction and osteoconduction that yields favorite bone regeneration outcomes. Demineralization of dentin is essential to release trapped growth factors, expose collagen fibrils and enhance the grafts degradability and replacement by native tissues. Many acids have been investigated for the use in chairside preparation of the dentin graft and hence, clinicians are faced with different choices but little evidence regarding the acid which yield s better outcomes.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

Status
unknown

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

First Submitted

Initial submission to the registry

May 14, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 19, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
Last Updated

July 15, 2020

Status Verified

July 1, 2020

Enrollment Period

11 months

First QC Date

May 14, 2020

Last Update Submit

July 13, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Radiographic bone changes

    width and height losses (quantitative in mm)

    6 months

Secondary Outcomes (2)

  • histological analysis

    6 months

  • soft tissue healing

    Biweekly for 6 weeks

Study Arms (2)

autogenous dentin graft treated with nitric acid

EXPERIMENTAL
Procedure: Alveolar ridge preservation after extraction

autogenous dentin graft treated with hydrochloric acid

ACTIVE COMPARATOR
Procedure: Alveolar ridge preservation after extraction

Interventions

atraumatic extraction followed by graft material insertion

autogenous dentin graft treated with hydrochloric acidautogenous dentin graft treated with nitric acid

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Non-restorable teeth
  • medically healthy
  • able to provide informed consent and attend follow-up period

You may not qualify if:

  • pregnant
  • smokers or alcoholic
  • severe bone loss

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Split-mouth prospective randomized clinical trial with 1:1 assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 14, 2020

First Posted

May 19, 2020

Study Start

October 1, 2020

Primary Completion

August 31, 2021

Study Completion

October 31, 2021

Last Updated

July 15, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share