Bone Loss, AlveolarPhase 3XEOLASNCT05602493
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
A Phase 3 study testing Soludronate® and sterile saline in people with Bone Loss, Alveolar, run by Xeolas Pharmaceuticals Limited at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Bone Loss, Alveolar
- What is being tested?
- Soludronate® and sterile saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 22 Nov 2022to 20 Oct 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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®.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Universitat Internacional de Catalunya
Sant Cugat del Vallès, Barcelona, 08195
About this study
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´
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.
Read the 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.
- Conditions
- Bone Loss, Alveolar
- Being tested
- Soludronate®, sterile saline
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soludronate®Drug
In the first visit, the randomized process will take place. Tooth extraction procedure will be performed.
sterile salineDrug
sterile saline
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: sterile saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day 1
Secondary outcomes (1)
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.
Measured: 1 day to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start22 Nov 2022
- Primary completion20 Oct 2024 (estimated)
- Study completion20 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Loss, AlveolarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective Randomized Clinical Trial Phase (IIIa), Unicentric, Placebo Controlled, Double-Blinded Study"
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xeolas Pharmaceuticals Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dennis McDaid, PhD, Study director, Xeolas Pharmaceuticals Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05602493
- Sponsor's protocol ID
- XeolasPharma
- Acronym
- XEOLAS
- Status last verified
- Sep 2024
- First submitted
- 27 Oct 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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´
- ClinicalTrials.gov ID
- NCT05602493
- Acronym / sponsor ID
- XEOLAS / XeolasPharma
- Conditions
- Bone Loss, Alveolar
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Xeolas Pharmaceuticals LimitedIndustry (pharma, biotech, devices)
- Study start
- 22 Nov 2022 (actual)
- Primary completion
- 20 Oct 2024 (estimated)
- Study completion
- 20 Oct 2024 (estimated)
- First posted
- 2 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Prospective Randomized Clinical Trial Phase (IIIa), Unicentric, Placebo Controlled, Double-Blinded Study"
| Arm | Type | Receives |
|---|---|---|
| test group (n=30) Soludronate® 0.7 mg/ml | Experimental | Drug: Soludronate®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. |
| control group (n=30) sterile saline | Placebo comparator | Drug: sterile salineIt 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soludronate®In the first visit, the randomized process will take place. Tooth extraction procedure will be performed. | Drug | test group (n=30) Soludronate® 0.7 mg/ml |
| sterile salinesterile saline | Drug | control group (n=30) sterile saline |
Primary outcome
Buccal and lingual vertical and horizontal bone socket dimensions will be measured by CBCT.
Time frame: Day 1
Three dimensional volumetric changes in hard tissue will be measured in (mm).
1 secondary outcome
Record any adverse effect and their severity related to the Soludronate® or its use.
Time frame: 1 day to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dennis McDaid, PhD study director
Xeolas Pharmaceuticals Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Soludronate® and sterile saline in people with Bone Loss, Alveolar, run by Xeolas Pharmaceuticals Limited at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Buccal and lingual vertical and horizontal bone socket dimensions will be measured by CBCT. (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.