NCT06016218 is a Phase 1, PHASE2 clinical trial of Simvastatin in Dental Caries Extending to Pulp, sponsored by British University In Egypt.

Who is sponsoring NCT06016218?

NCT06016218 is sponsored by British University In Egypt.

What drugs are being tested in NCT06016218?

Interventions in NCT06016218: Simvastatin.

What condition does NCT06016218 study?

NCT06016218 studies Dental Caries Extending to Pulp, Dental Implant Failed.

Is NCT06016218 still recruiting?

NCT06016218 is currently completed. Last updated 6 September 2023.

Last reviewed 2023-09-06 · How we verify

NCT06016218

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Effect of Local Application of Simvastatin Versus Bone Powder on Implant Bone Changes

Completed Phase 1, PHASE2 Last updated 6 September 2023

What this trial tests

Phase 1, PHASE2 trial testing Simvastatin in Dental Caries Extending to Pulp in 24 participants. Completed in 5 February 2023.

Timeline

5 January 2021

Primary endpoint
5 January 2022

5 February 2023

Quick facts

Lead sponsor	British University In Egypt
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	24
Start date	5 January 2021
Primary completion	5 January 2022
Estimated completion	5 February 2023
Sites	1 location across Egypt

Drugs / interventions tested

Simvastatin (simvastatin) — full drug profile →

Conditions studied

Dental Caries Extending to Pulp — all drugs for Dental Caries Extending to Pulp →
Dental Implant Failed — all drugs for Dental Implant Failed →

Sponsor

British University In Egypt

Who can join

Adults 45 to 60, male only, with Dental Caries Extending to Pulp or Dental Implant Failed. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is conducted A- To investigate that PRF loaded with osteopromotive pharmacological drug can be a great aid in implant rehabilitation, and whether it could be a replacement for the other high price bone graft materials or not. This will be done through: 1. Measuring bone changes around the implant by cone beam 2. Measuring change in bone density around the implants B- Evaluate the effect of statins on osteoblasts activity and expression of various osteogenic products in vitro.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Simvastatin Enhances Stem Cell Osteogenesis and Reduces Peri-Implant Bone Loss: An In Vitro and a Randomized Clinical Study.
Saleh A, Raafat SN, Sayed SA, Shamel M, et al · · 2026 · PMID 41901215 · DOI 10.3390/ph19030368

Verify or expand the search:

Other trials of Simvastatin

Trials testing the same drug.

NCT07102979 — Remedial Mechanism of Simvastatin and Ursodeoxycholic Acid in Liver Cirrhosis: Crosstalk of Bile Secretion, Gut Microbio · NA · enrolling by invitation
NCT06948747 — A Study to Investigate the Effect of AZD5004 on Rosuvastatin, Atorvastatin, Simvastatin, Repaglinide and the Effect of E · Phase 1 · completed
NCT06858332 — Lipoprotein(a) Levels in Patients With Atherosclerotic Cardiovascular Diseases in Russia · recruiting
NCT07031778 — Topic Simvastatin for Bone Regeneration · EARLY_PHASE1 · recruiting
NCT06399783 — Topical Simvastatin Versus Topical Steroid in Treatment of Alopecia Areata · Phase 4 · not yet recruiting

Other recruiting trials for Dental Caries Extending to Pulp

Currently open trials in the same condition.

NCT06844448 — The Effect of Different Risk Factors on the Success Rate of VPT · recruiting

Other British University In Egypt trials

Trials by the same sponsor.

NCT07492576 — Evaluation of the Magnesium Shield Compared to Dual Zone Grafting Approach in Immediate Implant Site Management · NA · recruiting
NCT07457749 — Clinical Performance of a Novel Self-cured Resin Composite Compared to a Light-cured Bioactive Resin Composite Restorati · EARLY_PHASE1 · recruiting
NCT07368621 — Effectiveness of Connective Tissue Graft With and Without Leukocyte Platelet Rich Fibrin on Peri-implant Soft Tissue Thi · NA · recruiting
NCT07480070 — Two-Year Clinical Performance of Self-Cured Resin Composite in Comparison to Light-Cured Bioactive Resin Composite in Re · NA · completed
NCT07115758 — Vestibular Versus Trapezoid Flap in Immediate Implants · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06016218 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by British University In Egypt
Last refreshed: 6 September 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06016218.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing