NCT05536492

Brief Summary

In this research investigators are going to detect the effect of using different type of materials(sticky bone\\platlet rich fibrin ) compared to normal healing on the dimensional changes of alveolar crest after single rooted tooth extraction by using CBCT (cone-beam computed tomography) at time of extraction and after 16-24 weeks

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

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 5, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

September 7, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 13, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

October 11, 2023

Status Verified

October 1, 2023

Enrollment Period

1.1 years

First QC Date

September 5, 2022

Last Update Submit

October 8, 2023

Conditions

A-PRFALLOGRAFT

Outcome Measures

Primary Outcomes (2)

  • RIDGE DIMENSIONS

    USING CBCT

    4 Months

  • BONE DENSITY

    USING CBCT

    4 MONTHS

Study Arms (3)

G1-Control group

NO INTERVENTION

normal socket healing after extraction without intervention

G2

EXPERIMENTAL

SOCKET AUGMENTATION WITH A-PRF ALONE

Procedure: A-PRF

G3

EXPERIMENTAL

SOCKET AUGMENTATION WITH A-PRF + ALLOGRAFT

Procedure: A-PRFProcedure: ALLOGRAFT

Interventions

A-PRFPROCEDURE

EXTRACTION FOR SINGLE rooted tooth followed by augmentation with PRF

G2G3
ALLOGRAFTPROCEDURE

EXTRACTION FOR SINGLE rooted tooth followed by augmentation with PRF + ALLOGRAFT

G3

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • presence of the buccal and palatal/lingual bony walls evaluated clinically by measuring the thickness of the alveolar ridge and radiologically by a CBCT , and residual periodontal attachment of at least 6 mm of single rooted tooth

You may not qualify if:

  • complicated tooth extraction, and any medical problem that could interfere with the mucosal and bony healing processes or contraindicating an implant placement, such as anticoagulation, antiaggregatory medication, radiotherapy, bisphosphonate therapy, diabetes, endocarditis risk factors, immunosuppression, and renal or hepatic failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ArabAmericanU

Ramallah, West Bank, Palestinian Territories

Location

MeSH Terms

Interventions

Transplantation, Homologous

Intervention Hierarchy (Ancestors)

TransplantationSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dentist and clinical Msc student

Study Record Dates

First Submitted

September 5, 2022

First Posted

September 13, 2022

Study Start

September 7, 2022

Primary Completion

September 30, 2023

Study Completion

October 1, 2023

Last Updated

October 11, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)