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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
Conditions: Bone Loss, Alveolar
Sex: All
Ages: 18 Years – 90 Years
Phase: PHASE3
Enrollment: 60
Sponsor: Xeolas Pharmaceuticals Limited
Location: Spain
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.
Eligibility 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 womanAlcohol 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®.
Source: ClinicalTrials.gov (NCT05602493). StuddyBuddy aggregates publicly available trial information.