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

• Status: Not yet recruiting
• Trial end date: 2023-04-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xeolas Pharmaceuticals Limited

Criteria

Inclusion Criteria:

• Provide signed and dated informed consent form.

• Overall, healthy patients that qualify for oral surgery (ASA I and II).

• Male and female patients 18-90 (inclusive) years of age.

• Requiring extraction of 1 tooth (maxillary or mandibular).

• Stable post-extraction socket walls with at least 4 walls.

• Adequate oral hygiene: plaque index < 25% before the surgery.

• Non-smoker or smoker of <10 cigarettes per day.

• Able to follow the instructions and able to meet the follow-ups.

• Healthy or controlled periodontal disease.

Exclusion Criteria:

• Patients who do not agree with informed consent.

• Male and female patients are not 18-90 (inclusive) years of age. Patients taking medication that can interfere with the treatment such as Calcium Carbonate or Vitamin D.

• Untreated periodontal disease.

• Presence of dehiscence and/or fenestration at buccal plate of the extraction tooth/teeth.

• Patient who will need guided bone regeneration (GBR) or Block Regeneration after the extraction.

• History of head and/or neck radiation.

• History of chemotherapy in the five years prior of the surgery.

• Non controlled Diabetes.

• Chronic corticoids medication that may influence healing and/or osseointegration.

• Smoker of >10 cigars per day.

• Pregnant woman

• Alcohol or drugs.

• Patient going under bisphosphonates treatment or taking Denosumab (Prolia®).

• Patient with diagnosed osteoporosis, hypocalcemia, hypersensibility to alendronic acid or any of the excipients of Soludronate®.