NCT05347017

Brief Summary

The aim of this trial is to compare the effect of autogenous demineralized dentin block graft (ADDBG) versus autogenous bone block graft (ABBG) harvested from maxillary tuberosity on alveolar ridge preservation after extraction of non-restorable single rooted teeth

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 26, 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
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

May 2, 2022

Status Verified

April 1, 2022

Enrollment Period

7 months

First QC Date

April 20, 2022

Last Update Submit

April 27, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Alveolar ridge bucco-lingual width change in mm

    Alveolar bone linear width will be measured at baseline and after 6 months using 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 measured in millimetres (Jung et al., 2013)

    6 months

Secondary Outcomes (2)

  • Alveolar ridge apico-coronal height change in mm

    6 months

  • Histological assessment

    6 months

Study Arms (2)

Alveolar ridge preservation using autogenous demineralized dentin block graft

EXPERIMENTAL

Atraumatic extraction of non-restorable teeth, then the extracted tooth will be prepared and demineralized using HCL acid as demineralized dentin block graft and inserted in the extraction socket

Procedure: Alveolar ridge preservation using autogenous demineralized dentin block graft

Alveolar ridge preservation using autogenous bone block graft

ACTIVE COMPARATOR

Atraumatic extraction of non-restorable teeth, then autogenous bone block will be harvested from the maxillary tuberosity and reshaped and inserted in the extraction socket

Procedure: Alveolar ridge preservation using autogenous bone block graft

Interventions

Atraumatic extraction of non restorable tooth, then the extracted tooth will be prepared and demineralized by HCL acid and inserted as demineralized dentin block graft in the socket

Alveolar ridge preservation using autogenous demineralized dentin block graft

Atraumatic extraction of non restorable tooth, then the autogenous bone block graft will be harvested from the maxillary tuberosity and reshaped and inserted into the socket

Alveolar ridge preservation using autogenous bone block 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
  • 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)

Faculty of dentistry

Cairo, Egypt

Location

Related Publications (5)

  • Jung RE, Philipp A, Annen BM, Signorelli L, Thoma DS, Hammerle CH, Attin T, Schmidlin P. Radiographic evaluation of different techniques for ridge preservation after tooth extraction: a randomized controlled clinical trial. J Clin Periodontol. 2013 Jan;40(1):90-8. doi: 10.1111/jcpe.12027. Epub 2012 Nov 19.

    PMID: 23163915BACKGROUND
  • Wong RW, Rabie AB. Effect of bio-oss collagen and collagen matrix on bone formation. Open Biomed Eng J. 2010 Mar 9;4:71-6. doi: 10.2174/1874120701004010071.

    PMID: 20461225BACKGROUND
  • Barootchi S, Wang HL, Ravida A, Ben Amor F, Riccitiello F, Rengo C, Paz A, Laino L, Marenzi G, Gasparro R, Sammartino G. Ridge preservation techniques to avoid invasive bone reconstruction: A systematic review and meta-analysis: Naples Consensus Report Working Group C. Int J Oral Implantol (Berl). 2019;12(4):399-416.

    PMID: 31781696BACKGROUND
  • Younes R, Khairallah CM. The "One Piece" Autologous Tuberosity Graft: A Contemporary Concept in Ridge Preservation. Case Rep Dent. 2020 Feb 13;2020:3945076. doi: 10.1155/2020/3945076. eCollection 2020.

    PMID: 32099685BACKGROUND
  • Kim, Y., Fajardo, K., Valera, A. and Um, I. (2017) 'Autogenous Tooth Bone Graft Block For Socket Preservation: A One-Stage Technique', Dentistry, 7(414), pp. 2161-1122.1000414.

    BACKGROUND

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Central Study Contacts

Mohamed Talaat, Master Degree

CONTACT

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. Mohamed Elbehwashy

Study Record Dates

First Submitted

April 20, 2022

First Posted

April 26, 2022

Study Start

June 1, 2022

Primary Completion

January 1, 2023

Study Completion

July 1, 2023

Last Updated

May 2, 2022

Record last verified: 2022-04

Locations