Comparison of The Post-Extraction Dimensional Alterations Following Ridge Preservation Using Autogenous Partially and Completely Demineralized Dentin Grafts Versus Autogenous Whole-tooth Graft

NCT05766137 | Unknown

• 1 other identifier: DinaAbdelwahabPerio
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

For alveolar ridge preservation after extraction of a non-restorable maxillary non-molar tooth, will the use of Autogenous partially or completely demineralized dentin grafts result in similar ridge dimensions compared to Autogenous whole-tooth graft?

Conditions

Socket Preservation, Alveolar Ridge Deficiency, Alveolar Ridge Preservation

Outcome Measures

Primary Outcomes (1)

• Alveolar ridge width and height changes

  Difference in alveolar ridge width and height linear measurements in millimeters between baseline and final CBCT scans after 6 months

  6 months

Secondary Outcomes (1)

• Histological assessment

  6 months

Study Arms (3)

Ridge preservation by filling the socket with autogenous partially demineralized dentin graft

EXPERIMENTAL

2% HNO3 partial demineralization for 10 minutes

Procedure: Alveolar ridge preservation

Ridge preservation by filling the socket with autogenous completely demineralized dentin graft

EXPERIMENTAL

0.6N HCl for 30 minutes for complete demineralization

Procedure: Alveolar ridge preservation

Ridge preservation by filling the socket with autogenous whole-tooth graft (AWTG).

ACTIVE COMPARATOR

After cleaning the tooth, it will be ground using bone mill and AWTG 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: Alveolar ridge preservation

Interventions

Alveolar ridge preservation PROCEDURE

Socket preservation

Ridge preservation by filling the socket with autogenous completely demineralized dentin graft; Ridge preservation by filling the socket with autogenous partially demineralized dentin graft; Ridge preservation by filling the socket with autogenous whole-tooth graft (AWTG).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-molar maxillary teeth indicated for extraction.
• Extraction sockets having no more than 50% of buccal alveolar bone loss were included.
• 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:

• Infection at the extraction site
• Smokers
• Patients undergoing or having history of radiotherapy, chemotherapy or bisphosphonate therapy.
• Systemic conditions that may compromise healing or bone metabolism (e.g., uncontrolled diabetes, hyperthyroidism).
• Females that are pregnant or are planning to get pregnant during the study course.

Sponsors & Collaborators

• Cairo University: lead

Central Study Contacts

Dina Abdelwahab, M.Sc.

CONTACT

0201003808409; dina.osama@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: * Blinding of the operator is not applicable. * Participants, outcome assessors and biostatistician will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Model Details: Parallel-group with allocation ratio of 1:1:1

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: March 13, 2023
• Study Start: June 1, 2023
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2023
• Last Updated: April 6, 2023

Record last verified: 2023-04