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

NCT05602493 | Active Not Recruiting Phase 3

• 1 other identifier: XeolasPharma
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bone Loss, Alveolar

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Record any adverse effect and their severity related to the Soludronate® or its use.

  1 day to 3 months

Study Arms (2)

test group (n=30) Soludronate® 0.7 mg/ml

EXPERIMENTAL

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.

Drug: Soludronate®

control group (n=30) sterile saline

PLACEBO COMPARATOR

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.

Drug: sterile saline

Interventions

Soludronate® DRUG

In the first visit, the randomized process will take place. Tooth extraction procedure will be performed.

test group (n=30) Soludronate® 0.7 mg/ml

sterile saline DRUG

sterile saline

control group (n=30) sterile saline

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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®.

Sponsors & Collaborators

• Xeolas Pharmaceuticals Limited: lead

Study Sites (1)

Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, 08195, Spain

Location

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Dennis McDaid, PhD

  Xeolas Pharmaceuticals Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-Blinded Study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective Randomized Clinical Trial Phase (IIIa), Unicentric, Placebo Controlled, Double-Blinded Study"

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: November 2, 2022
• Study Start: November 22, 2022
• Primary Completion: October 20, 2024
• Study Completion: October 20, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

ES (1)