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 (XEOLAS)
Bone Loss, Alveolar
About this trial
This is an interventional treatment trial for Bone Loss, Alveolar
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 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®.
Sites / Locations
- Universitat Internacional de CatalunyaRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
test group (n=30) Soludronate® 0.7 mg/ml
control group (n=30) sterile saline
It will be applied on the fresh extraction socket for 15 min and then rinsed with sterile saline 3 time, 1 minute each rinse. After the extraction will be required a CBCT scan. The medication that will be prescribed for the patient will be Enantyum 25 mg (2-3 days) and in case of allergic patient Paracetamol 650 mg (2-3 days). 15 days later (-/+ 2 days), during the follow-up 1 the suture will be removed, the cicatrization of the surgical site evaluated and intraoral photos will be taken. The last follow-up (2) visit, 91 days later (-/+ 2 day) the follow-up 2 will take place. A CBCT scan and intraoral photos will be required.
It will be applied on the fresh extraction socket for 15 min and then rinsed with sterile saline 3 time, 1 minute each rinse. After the extraction will be required a CBCT scan. The medication that will be prescribed for the patient will be Enantyum 25 mg (2-3 days) and in case of allergic patient Paracetamol 650 mg (2-3 days). 15 days later (-/+ 2 days), during the follow-up 1 the suture will be removed, the cicatrization of the surgical site evaluated and intraoral photos will be taken. The last follow-up (2) visit will be 1,5 months after the intervention and will be optional for those cases showing redness, swelling or pain during the first follow up, 3,5 months later (-/+ 1 week) the end visit will take place. A CBCT scan and intraoral photos will be required at the end visit.