NCT05536479

Brief Summary

Tooth extraction triggers a cascade of biological events mediated by both the local inflammatory response that follows the surgical intervention and the deprivation of masticatory stimulation of the periodontium, which elicit an alteration of the homoeostasis and structural integrity of the periodontal tissues. Bone remodeling kicks off after tooth loss and continues for several months with most changes taking place in the first three months. Interestingly, Schmidt-Schultz and Schultz, found that intact growth factors are conserved even in the collagenous extracellular matrix of ancient human bone and teeth. Thus, the application of stored dentin may have similar benefits as fresh dentin, preserving intact growth factors for a prolonged period avoiding the need to perform multiple surgical interventions simultaneously. The volume of the particulate dentin is more than twice of the original root volume. Thus, the idea of using autogenous stored mineralized dentin grafts (ASMDG) in ARP evolved.

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
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 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

September 8, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 10, 2022

Completed
21 days until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

September 10, 2022

Status Verified

September 1, 2022

Enrollment Period

7 months

First QC Date

September 8, 2022

Last Update Submit

September 8, 2022

Conditions

Alveolar Bone Loss

Outcome Measures

Primary Outcomes (1)

  • Change in buccolingual horizontal alveolar ridge width

    The horizontal buccolingual alveolar ridge width will be measured radiographically on a CBCT at three levels: at -1 mm, -3 mm, -5 mm below the most coronal aspect of the crest (HW-1, HW-3, HW-5), and clinically by a caliper at -3 mm and -5 mm (HW-3 and HW-5). Measurements will be taken at baseline and after 4 months postoperatively to calculate the change.

    4 months

Secondary Outcomes (2)

  • Alveolar buccal ridge height

    4 months

  • Postoperative pain

    24 hours

Study Arms (2)

Autogenous stored mineralized dentin graft (ASMDG)

EXPERIMENTAL

Autogenous stored mineralized dentin graft (ASMDG) particles will be prepared by immersing tooth particles in basic ethanol for 10 min for disinfection, then washed twice in saline and dried using sterile gauze The disinfected particles will then be stored at room temperature for 21 days in a sterile container. After 21 days, a second extraction will be performed followed by mixing the stored graft with a few drops of sterile saline to be packed in a socket after extraction

Procedure: Autogenous stored mineralized dentin graft (ASMDG)

Autogenous fresh mineralized dentin graft (AFMDG)

ACTIVE COMPARATOR

Autogenous fresh mineralized dentin graft (AFMDG) particles will be prepared by immersing tooth particles in basic ethanol for 10 min for disinfection, then washed twice in saline and dried using sterile gauze

Procedure: Autogenous fresh mineralized dentin graft (AFMDG)

Interventions

Autogenous stored mineralized dentin graft (ASMDG)PROCEDURE

Autogenous stored mineralized dentin graft (ASMDG) particles will be prepared by immersing tooth particles in basic ethanol for 10 min for disinfection, then washed twice in saline and dried using sterile gauze. The disinfected particles will then be stored at room temperature for 21 days in a sterile container. After 21 days, a second extraction will be performed followed by mixing the stored graft with a few drops of sterile saline to be packed in a socket after extraction

Autogenous stored mineralized dentin graft (ASMDG)
Autogenous fresh mineralized dentin graft (AFMDG)PROCEDURE

Autogenous fresh mineralized dentin graft (AFMDG) particles will be prepared by immersing tooth particles in basic ethanol for 10 min for disinfection, then washed twice in saline and dried using sterile gauze.

Autogenous fresh mineralized dentin graft (AFMDG)

Eligibility Criteria

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

You may qualify if:

  • Potential candidates requiring extraction of maxillary non-molar teeth.
  • Periodontally healthy adjacent teeth.
  • Extraction sockets having no more than 50% of buccal alveolar bone loss

You may not qualify if:

  • Smokers.
  • Patients reporting systemic conditions that may compromise healing or bone metabolism (e.g., uncontrolled diabetes, hyperthyroidism).
  • Patients having a history of radiotherapy, chemotherapy, or bisphosphonate therapy.
  • Females who were pregnant or planning to get pregnant during the study course.
  • Root canal treated teeth and teeth with acute infection at the site of extraction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university

Cairo, Egypt

Location

Related Publications (2)

  • Avila-Ortiz G, Chambrone L, Vignoletti F. Effect of alveolar ridge preservation interventions following tooth extraction: A systematic review and meta-analysis. J Clin Periodontol. 2019 Jun;46 Suppl 21:195-223. doi: 10.1111/jcpe.13057. Erratum In: J Clin Periodontol. 2020 Jan;47(1):129. doi: 10.1111/jcpe.13212.

    PMID: 30623987BACKGROUND

  • Schmidt-Schultz TH, Schultz M. Intact growth factors are conserved in the extracellular matrix of ancient human bone and teeth: a storehouse for the study of human evolution in health and disease. Biol Chem. 2005 Aug;386(8):767-76. doi: 10.1515/BC.2005.090.

    PMID: 16201872BACKGROUND

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Central Study Contacts

Nada Wahsh, Bachelor

CONTACT

01026191091nada.wahsh@dentistry.cu.edu.eg

Cairo University

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. Nada Wahsh

Study Record Dates

First Submitted

September 8, 2022

First Posted

September 10, 2022

Study Start

October 1, 2022

Primary Completion

May 1, 2023

Study Completion

September 1, 2023

Last Updated

September 10, 2022

Record last verified: 2022-09

Locations

EG(1)