NCT06617221

Brief Summary

The goal of this clinical trial is to determine whether a graft material introduced recently (test) to be used in extraction sockets is as good as a previously known graft material (control) in adults undergoing tooth extraction of a single-rooted tooth. The main question it aims to answer is: Is this graft material able to maintain good bone volume and composition after extraction? Researchers will compare this new graft to a well-studied graft material. Participants will be randomly assigned to one of the groups and will receive the allocated graft after tooth extraction. The dimension of the alveolar ridge, which supports teeth in the jaw, will be measured before extraction and four months after healing. A cone beam CT Scan will also be obtained.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration 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

January 1, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 25, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 27, 2024

Completed
Last Updated

October 1, 2024

Status Verified

September 1, 2024

Enrollment Period

2.2 years

First QC Date

September 25, 2024

Last Update Submit

September 27, 2024

Conditions

Extraction Socket HealingSocket PreservationAlveolar Ridge Preservation

Outcome Measures

Primary Outcomes (1)

  • clinical and radiographic ridge alterations

    Using a standardized stent with reference points , the following horizontal clinical measurements were obtained before extraction through the stent holes: buccal soft tissue thickness at 4, 7, and 10 mm apical to the gingival margin and palatal or lingual soft tissue thickness at similar sites. Vertical measurements were obtained an incisal or occlusal hole to the buccal aspect of the ridge (inciso-buccal) and the palatal/ lingual aspect (inciso-palatal). Radiographic width of the alveolar ridge was measure at the same reference points. theses measurements were taken at baseline (before extraction) and at 4 months after extraction and socket graft

    four months

Study Arms (2)

Composite graft plug

EXPERIMENTAL

composite graft plug was placed in the socket after extraction

Biological: Composite graft plug

Allograft

ACTIVE COMPARATOR

allograft was placed in the socket after extraction

Biological: Allograft

Interventions

Composite graft plugBIOLOGICAL

after tooth extraction the socket was grafted with a composite graft plug

Composite graft plug
AllograftBIOLOGICAL

after tooth extraction the socket was grafted with allograft

Allograft

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • planned for extraction and alveolar ridge preservation of a single-rooted tooth - -- healthy or have well-controlled systemic disease
  • good oral hygiene
  • healthy periodontium or at least at the extraction area.

You may not qualify if:

  • smoking ≥10 cigarettes per day
  • generalized periodontitis
  • poor oral hygiene
  • uncontrolled systemic diseases such as diabetes
  • pregnancy
  • history of anti-resorptive therapy such as bisphosphonate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Abdulaziz University

Jeddah, Mecca Region, 21589, Saudi Arabia

Location

Related Publications (2)

  • Jafarian J, Shahrabi-Farahani S, Ferreira CF, Stewart CW, Luepke P. Histological Evaluation of Alveolar Ridge Preservation Using Different Bone Grafts: Clinical Study Analysis Part II. J Oral Implantol. 2024 Jun 1;50(3):260-265. doi: 10.1563/aaid-joi-D-23-00060.

    PMID: 38660739BACKGROUND

  • Jones K, Williams C, Yuan T, Digeorge-Foushee AM, Chambers Wilson R, Burton T, Hamlin N, Martinez L. Comparative in vitro study of commercially available products for alveolar ridge preservation. J Periodontol. 2022 Mar;93(3):403-411. doi: 10.1002/JPER.21-0087. Epub 2021 Jul 12.

    PMID: 34114665BACKGROUND

MeSH Terms

Interventions

Transplantation, Homologous

Intervention Hierarchy (Ancestors)

TransplantationSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

September 25, 2024

First Posted

September 27, 2024

Study Start

January 1, 2021

Primary Completion

March 1, 2023

Study Completion

June 1, 2023

Last Updated

October 1, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will share

Age, Medical condition, gender

Shared Documents
STUDY PROTOCOL, SAP, CSR

Locations

SA(1)