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ACTIVE NOT RECRUITING
NCT05602493
PHASE3

A Randomized Control Trial Phase (IIIa) Unicentric, Placebo Controlled, Double-Blinded Efficacy and Safety of Topical Alendronic Acid on Alveolar Bone Remodeling After Tooth Extraction

Sponsor: Xeolas Pharmaceuticals Limited

View on ClinicalTrials.gov

Summary

The purpose of the study is to determine the efficacy and safety of the effects of a topical medication on bone remodeling after dental extraction, in order to establish whether such treatment can be a new therapeutic option for said pathology. The participation of 60 patients is expected, who will be divided randomly in equal proportions into two groups. Treatment groups: Group A (30 patients): medication administered topically. Group B (30 patients): placebo with characteristics equal to the drug under investigation.

Official title: A Randomized Control Trial Phase (IIIa) Unicentric, Placebo Controlled, Double-Blinded Study to Confirm the Efficacy and Safety of 'Topical Alendronic Acid on Alveolar Bone Remodeling After Tooth Extraction: a Pilot Study´

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2022-11-22

Completion Date

2024-10-20

Last Updated

2024-09-19

Healthy Volunteers

No

Interventions

DRUG

Soludronate®

In the first visit, the randomized process will take place. Tooth extraction procedure will be performed.

DRUG

sterile saline

sterile saline

Locations (1)

Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, Spain