NCT05791123

Brief Summary

fourteen patients requiring extraction of one posterior tooth with lost buccal bone (\>50%) confirmed preoperatively by Cone-beam computed tomography (CBCT) scans. Extraction sockets were filled with minced PRF clots mixed with the bovine xenograft and covered by PRF membranes to seal the extraction sockets. (CBCT) scans, performed before tooth extraction and after 6 months, were used to assess vertical and horizontal bone changes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2018

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

July 15, 2018

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2023

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2023

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 8, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 30, 2023

Completed
Last Updated

March 30, 2023

Status Verified

March 1, 2023

Enrollment Period

4.6 years

First QC Date

March 8, 2023

Last Update Submit

March 17, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • the change in alveolar bone width and height in mm using CBCT scans.

    Cone Beam Computed Tomography were taken for each patients before tooth extraction and after 6 months, which were used to assess alveolar ridge changes in width and length in mm.

    6 months

Study Arms (1)

a bone graft mixed with PRF & covered by PRF membrane in fresh extraction socket

EXPERIMENTAL
Procedure: a bone graft mixed with PRF & covered by PRF membrane in fresh extraction socket

Interventions

Extraction sockets were filled with minced PRF clots mixed with the bovine xenograft and covered by PRF membranes to seal the extraction sockets.

a bone graft mixed with PRF & covered by PRF membrane in fresh extraction socket

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients required implant treatment after tooth extraction
  • Age group ranged from 20-60 years old.
  • Patients could undergo the treatment under local anesthesia.
  • Loss of buccal bone (\>50%) confirmed by preoperative cone beam computed tomography (CBCT).
  • Presence of other socket walls; mesial, distal and lingual walls.
  • Tooth needed to be extracted in upper or lower posterior regions

You may not qualify if:

  • Uncontrolled diabetic diseases.
  • Uncontrolled hypertension, or hepatic and renal disorders.
  • Any systemic diseases associated with bone metabolism.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Future University in Egypt

Cairo, Egypt

Location

Related Publications (1)

  • Elbanna RM, Abdelaziz MS, Alameldeen HE. Augmentation of single tooth extraction socket with deficient buccal walls using bovine xenograft with platelet-rich fibrin membrane. BMC Oral Health. 2023 Nov 17;23(1):874. doi: 10.1186/s12903-023-03554-2.

MeSH Terms

Interventions

Prolactin-Releasing Hormone

Intervention Hierarchy (Ancestors)

Hypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer of Prosthodontics

Study Record Dates

First Submitted

March 8, 2023

First Posted

March 30, 2023

Study Start

July 15, 2018

Primary Completion

February 20, 2023

Study Completion

March 5, 2023

Last Updated

March 30, 2023

Record last verified: 2023-03

Locations