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

Bone Loss, Alveolar Clinical Trial

— XEOLAS  

Official title:

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´

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05602493
• Other study ID #: XeolasPharma
• Status: Recruiting
• Phase: Phase 3
• Start date: November 22, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: July 2023
• Source: Xeolas Pharmaceuticals Limited
• Contact: Jordi Caballé Serrano, Dr.
• Phone: +34 935042000
• Email: jordicase[@]uic.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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®.

Related Conditions & MeSH terms

• Alveolar Bone Loss
• Bone Loss, Alveolar

Intervention

Drug:
• Soludronate®
In the first visit, the randomized process will take place. Tooth extraction procedure will be performed.
• sterile saline
sterile saline

Locations

Country	Name	City	State
Spain	Universitat Internacional de Catalunya	Sant Cugat Del Vallès	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Xeolas Pharmaceuticals Limited

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Buccal and lingual vertical and horizontal bone socket dimensions will be measured by CBCT.	Three dimensional volumetric changes in hard tissue will be measured in (mm).	Day 1
Secondary	Record any adverse effect and their severity related to the Soludronate® or its use.	First follow-up: assessments to be performed during the visit: control, suture removal, photos and evaluation of the surgical site at 15 days.; Second follow-up: optional visit, 1,5 months after the treatment. If the patient shows abnormal redness, swelling or pain in the first follow up, patient will be scheduled for a second visit.; End of the study: assessments to be performed during the visit: CBCT scan and intraoral photos at 3,5 months approximately after the treatment visit.	1 day to 3 months