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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)

Primary Purpose

Bone Loss, Alveolar

Status
Recruiting
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Soludronate®
sterile saline
Sponsored by
Xeolas Pharmaceuticals Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Loss, Alveolar

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Placebo Comparator

Arm Label

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

control group (n=30) sterile saline

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Full Information

First Posted
October 27, 2022
Last Updated
July 25, 2023
Sponsor
Xeolas Pharmaceuticals Limited
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1. Study Identification

Unique Protocol Identification Number
NCT05602493
Brief Title
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
Acronym
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´
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 22, 2022 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xeolas Pharmaceuticals Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Loss, Alveolar

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Prospective Randomized Clinical Trial Phase (IIIa), Unicentric, Placebo Controlled, Double-Blinded Study"
Masking
ParticipantInvestigator
Masking Description
Double-Blinded Study
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
test group (n=30) Soludronate® 0.7 mg/ml
Arm Type
Experimental
Arm Description
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.
Arm Title
control group (n=30) sterile saline
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Soludronate®
Intervention Description
In the first visit, the randomized process will take place. Tooth extraction procedure will be performed.
Intervention Type
Drug
Intervention Name(s)
sterile saline
Intervention Description
sterile saline
Primary Outcome Measure Information:
Title
Buccal and lingual vertical and horizontal bone socket dimensions will be measured by CBCT.
Description
Three dimensional volumetric changes in hard tissue will be measured in (mm).
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Record any adverse effect and their severity related to the Soludronate® or its use.
Description
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.
Time Frame
1 day to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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®.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jordi Caballé Serrano, Dr.
Phone
+34 935042000
Email
jordicase@uic.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis McDaid, PhD
Organizational Affiliation
Xeolas Pharmaceuticals Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Universitat Internacional de Catalunya
City
Sant Cugat Del Vallès
State/Province
Barcelona
ZIP/Postal Code
08195
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jordi Caballé Serrano, Dr.
Phone
+34935042000
Email
jordicase@uic.es
First Name & Middle Initial & Last Name & Degree
Jordi Caballé Serrano, Dr.
First Name & Middle Initial & Last Name & Degree
Federico Hernández Alfaro, Dr.
First Name & Middle Initial & Last Name & Degree
Maria Giralt Hernando, Dr.

12. IPD Sharing Statement

Learn more about this trial

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

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