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

Last updated: September 3, 2024
Sponsor: Xeolas Pharmaceuticals Limited
Overall Status: Active - Not Recruiting

Phase

3

Condition

Periodontitis

Treatment

sterile saline

Soludronate®

Clinical Study ID

NCT05602493
XeolasPharma
  • Ages 18-90
  • All Genders

Study 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

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

Exclusion Criteria:

  • Patients who do not agree with informed consent.

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

  • Untreated periodontal disease.

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

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

  • 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 alendronicacid or any of the excipients of Soludronate®.

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: sterile saline
Phase: 3
Study Start date:
November 22, 2022
Estimated Completion Date:
October 20, 2024

Study 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.

Connect with a study center

  • Universitat Internacional de Catalunya

    Sant Cugat Del Vallès, Barcelona 08195
    Spain

    Site Not Available

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