NCT05336149

Brief Summary

The aim of this trial is to compare whole-tooth vs particulate dentin for their effects in alveolar ridge preservation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

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

April 4, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 20, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

April 20, 2022

Status Verified

April 1, 2022

Enrollment Period

7 months

First QC Date

April 4, 2022

Last Update Submit

April 15, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Alveolar bone width change in mm

    Alveolar bone linear width will be measured at baseline at final cone beam computed tomography (CBCT) scans. The change in bone width will be calculated as the subtraction of final width from baseline width and will be expressed in millimetres.

    6 months

Secondary Outcomes (2)

  • Alveolar bone height change in mm

    6 months

  • Histological assessment

    6 months

Study Arms (2)

Whole-tooth dentin graft

EXPERIMENTAL

The extracted tooth will be prepared as whole-tooth dentin graft and inserted in the extraction socket.

Procedure: Alveolar ridge preservation using whole-tooth dentin graft

Particulate dentin graft

ACTIVE COMPARATOR

The extracted tooth will be prepared as particulate dentin graft and inserted in the extraction socket.

Procedure: Alveolar ridge preservation using particulate dentin graft

Interventions

Minimally-traumatic extraction of non-restorable teeth then grafting with whole-tooth dentin graft

Whole-tooth dentin graft

Minimally-traumatic extraction of non-restorable teeth then grafting with particulate dentin graft

Particulate dentin graft

Eligibility Criteria

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

You may qualify if:

  • Non-restorable tooth indicated for extraction
  • single-rooted teeth
  • Patients at least 18 years or older
  • Motivated patients, agree to sign informed consent and complete the follow-up period

You may not qualify if:

  • Pregnant females
  • active infection at extraction site
  • Smokers
  • systemic conditions affecting healing (e.g. diabetes, medications as bisphosphonates...)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 4, 2022

First Posted

April 20, 2022

Study Start

June 1, 2022

Primary Completion

January 1, 2023

Study Completion

June 1, 2023

Last Updated

April 20, 2022

Record last verified: 2022-04

Locations