NCT05602493

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

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´

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Xeolas Pharmaceuticals Limited · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. Subsequently, a review will be carried out 15 days later to assess the status of the intervention performed and a final visit 3 months after surgery. Neither the doctor nor the patient will know what treatment they will receive during the study. You will have a 50% chance of receiving the placebo, which will have the same characteristics in terms of color, texture and consistency; but it does not contain the pharmacologically active substance and therefore it is not expected to have an effect. Before the start of the study, it will be assessed if you accomplish the criteria of the study, you will be informed of all doubts and you must sign the patient informed consent form. You will need to attend study visits: Your participation in the study will last approximately 3.5 months. Throughout which you will have to go four times to the University Dental Clinic. On the 1st visit, the treatment group will be assigned together with dental extraction and application of the medication or placebo for 15 min. and you will have to rinse 3 times for 1 min. with sterile saline solution. A cone beam computed tomography (CBCT) scan will be performed and photos will be taken. The 2nd visit will take place after 15 days where the suture stitches will be removed and a review will be carried out where photos will be taken to assess the evolution. At approximately 3.5 months, both the imaging test (CBCT) and the photos will be repeated.

Conditions

• Bone Loss, Alveolar

Interventions

Type	Name	Description
DRUG	Soludronate®	In the first visit, the randomized process will take place. Tooth extraction procedure will be performed.
DRUG	sterile saline	sterile saline

Timeline

• Start date: 2022-11-22
• Primary completion: 2024-10-20
• Completion: 2024-10-20
• First posted: 2022-11-02
• Last updated: 2024-09-19

Locations

1 site across 1 country: Spain