Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05485194
Other study ID # HP-00102697
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 1, 2025
Est. completion date March 31, 2028

Study information

Verified date January 2024
Source University of Maryland, Baltimore
Contact Se-Lim Oh
Phone 4107063708
Email soh@umaryland.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

An animal study and our pilot human study demonstrated that placing a smooth-surface titanium bone screw (TBS) over the buccal plate of an extraction socket resulted in less dimensional changes of the alveolar ridge along with no adverse effects. The purpose of this randomized clinical trial is to investigate the effectiveness of TBS application for ridge preservation in comparison to (1) unassisted/non-interventional socket healing and (2) alveolar ridge preservation (ARP) approach using allografts and a membrane.


Description:

The participants will be randomized to one of the three groups: the non-intervention, titanium bone screw (TBS), and alveolar ridge preservation (ARP) groups. The sockets in the non-intervention group will be filled with blood clots only. One TBS will be placed over the labial/buccal plate of the extraction socket in the TBS group on the same day of the extraction. Allograft and resorbable collagen membrane will be used for the ARP group.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 150
Est. completion date March 31, 2028
Est. primary completion date March 31, 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - age =18 years - a tooth, which is in the area from the central incisor to the second premolar bounded by teeth (or implants) mesiodistally - a tooth requiring extraction Exclusion Criteria: - thyroid dysfunctions - diabetes mellitus - history of a chronic use of corticosteroids (>6 months) - history of oral/intravenous bisphosphonates within the past 2 years - smoking - history of other systemic conditions that could affect bone integrity.

Study Design


Intervention

Other:
Reducing dimensional changes following tooth extraction
Use of a titanium bone screw for ridge preservation following tooth extraction

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Maryland, Baltimore

References & Publications (2)

Joseph S, Oh SL, Pae EK, Joshi S. Use of transcortical miniscrews for alveolar ridge preservation following tooth extraction: A pilot study. Clin Oral Implants Res. 2022 Feb;33(2):150-157. doi: 10.1111/clr.13875. Epub 2021 Nov 16. Erratum In: Clin Oral Im — View Citation

Melsen B, Huja SS, Chien HH, Dalstra M. Alveolar bone preservation subsequent to miniscrew implant placement in a canine model. Orthod Craniofac Res. 2015 May;18(2):77-85. doi: 10.1111/ocr.12058. Epub 2014 Nov 18. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The width of the alveolar bone Dimensional changes in the width of the alveolar bone following tooth extraction up to 6 months
See also
  Status Clinical Trial Phase
Completed NCT04166890 - Comparison of the Efficacy and Safety of Two Homologous Active Principles for Local Dental Anesthesia Phase 4
Active, not recruiting NCT02952209 - The Effect of Alveolar Ridge Preservation After Tooth Extraction in the Posterior Maxilla N/A
Completed NCT02155764 - Ridge Preservation With New Class of Osteoplastic Materials Phase 2
Completed NCT01588444 - Ridge Preservation After Tooth Extraction Using Cortical Versus Cancellous Freeze Dried Bone Allograft N/A
Completed NCT00387140 - A Study to Evaluate the Safety and Efficacy of an Investigational Drug in the Treatment of Postoperative Dental Pain (MK-2295-005) Phase 2
Recruiting NCT06245161 - Efficacy of Computer Controlled Intraosseous Anesthesia in Pediatric Dental Patients N/A
Recruiting NCT05615272 - Treatment of Alveolar Osteitis: Traditional or Regenerative? N/A
Completed NCT05101954 - Platelet Rich Fibrin and Concentrated Growth Factors on Osseointegration of Immediate Implants N/A
Completed NCT03985033 - The Clinical and Biological Effects of Leucocyte and Platelet-rich Fibrin (L-PRF) on Post-extraction Sockets Healing N/A
Completed NCT04082598 - Antibiotic Therapy in Erupted Tooth Extractions Phase 4
Completed NCT01924390 - Histological Comparison of Ridge Preservation Using Mineralized FDBA Alone Versus a Combined Mineralized-Demineralized Freeze Dried Bone Allograft N/A
Completed NCT04930497 - Vestibular Socket Therapy With and Without Bone Grafting N/A
Completed NCT03191448 - Ridge Preservation Using FDBA and a Collagen Wound Dressing in Molar Sites N/A
Completed NCT03211312 - Prediction Model of Cardiac Risk for Dental Extraction in Elderly Patients With Cardiovascular Diseases
Withdrawn NCT06038695 - Immediate Implant Placement Using Volume-Stable Collagen Matrix Combined With rhPDGF-BB N/A
Completed NCT05845437 - On Adequacy of Referrals to Oral and Maxillofacial Surgery
Recruiting NCT05220462 - Remimazolam vs Midazolam Cognitive and Motor Recovery After Intravenous Conscious Sedation for Dental Extractions. Phase 3
Active, not recruiting NCT03943680 - Plasma Rich in Growth Factors in Post-extraction Sockets N/A
Recruiting NCT05106855 - Comparative Study of Immediate Single Unit Implants in Early Loading Protocols, With or Without Photobiomodulation. N/A
Completed NCT03487718 - A 14 Weeks Longitudinal Study to Investigate the Effect of Leukocyte- Platelet Rich Fibrin Plug on the Quality of the Newly Formed Bone in Ridge Preservation Procedure Following a Tooth Extraction. It is a Clinical, Radiographic and Histomorphometric Study. N/A