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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
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
Conditions
Interventions
Soludronate®
In the first visit, the randomized process will take place. Tooth extraction procedure will be performed.
sterile saline
sterile saline
Locations (1)
Universitat Internacional de Catalunya
Sant Cugat del Vallès, Barcelona, Spain