Bone ResorptionPhase 2NCT03980847
Evaluation, the Histomorphometric Study of Nanocrystalline Hydroxyapatite (Nano Bone) Wif Alendronate in the Preservation of the Tooth Socket
A Phase 2 study testing Alendronate 20 mg and Nanocrystal hydroxyapatite in people with Bone Resorption, run by Islamic Azad University, Sanandaj at 1 site in Iran.
Trial summary
Twenty patients referring to periodontics department of Boroujerd Azad university of dentistry after obtaining consent to participate in teh research project, which TEMPhas more TEMPthan 20 teeth, are over 18 years old and require socket preservation surgery to tooth extraction for teh periodontal problem, caries or… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Resorption
- What is being tested?
- Alendronate 20 mg and Nanocrystal hydroxyapatite
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIran
- Study dates
- 23 Feb 2018to 25 Apr 2019
- Phase
- Phase 2
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- at least 18 years old
- tooth fracture, root caries
- Patients are volunteered for placement of teh implant
Who cannot join
- systemic diseases
- Pregnancy and breastfeeding
- malignancy, radiation therapy,
- history of periodontal surgery during teh six months ago.
- medicine(phosphonates, antibiotic,...)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Teh Histomorphometric Study of Nanocrystalline Hydroxyapatite (Nano Bone) Wif Alendronate in Teh Preservation of Teh Tooth Socket
Twenty patients referring to periodontics department of Boroujerd Azad university of dentistry after obtaining consent to participate in teh research project, which TEMPhas more TEMPthan 20 teeth, are over 18 years old and require socket preservation surgery to tooth extraction for teh periodontal problem, caries or Fractures were selected.
Read the detailed description
20 healthy patients referring to periodontics department of Boroujerd Azad university of dentistry after obtaining consent to participate in the research project, which has more than 20 teeth, are over 18 years old and require socket preservation surgery to tooth extraction for the periodontal problem, caries or Fractures were selected. Furthermore, divided the socket randomly to two groups(A, B)including A: bone graft wif Alendronate and B: bone graft alone, after 3 months wif trephine will collect the samples. following the histomorphometric analysis.
- Conditions
- Bone Resorption
- Being tested
- Alendronate 20 mg, Nanocrystal hydroxyapatite
- Medical subject headings
- Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alendronate 20 mgDrug
Also called Group A
The Alendronate 20 mg combined with nanocrystalline hydroxyapatite as a synthetic bone substitute for socket preservation after tooth extraction
Nanocrystal hydroxyapatiteProcedure or surgery
Also called Group B
Postextraction Sockets Preserved With Nanocrystal hydroxyapatite as a synthetic bone substitute alone as a bone graft
| Study group | Role | What they receive |
|---|---|---|
| Alendronate 20 mg with bone graft | Active comparator | after tooth extraction, put teh Alendronate 20mg with bone graft within teh tooth socket Receives: Drug: Alendronate 20 mg |
| bone graft alone | Active comparator | after tooth extraction, put the bone graft within the tooth socket Receives: Drug: Alendronate 20 mg; Procedure: Nanocrystal hydroxyapatite |
What is being measured
The primary outcome is the main question the study is designed to answer.
New bone formation (bone area as percent)
Combination Lovastatin produced increased vital bone more percentage compared to the nanocrystal bone graft alone group. The new bone formation and alveolar ridge preservation with bone graft after extraction of pre-molar teeth could result in the maintenance of sufficient bone volume to place an implant in an ideal restorative position without the need for auxiliary implant site development procedures.
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study start23 Feb 2018
- Primary completion10 Mar 2019
- Study completion25 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone ResorptionStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Islamic Azad University, Sanandaj
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amirhossein Farahmand, Islamic Azad University, Sanandaj
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03980847
- Sponsor's protocol ID
- 2036
- Status last verified
- Jun 2019
- First submitted
- 13 May 2019
- Last updated
- 11 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Teh Histomorphometric Study of Nanocrystalline Hydroxyapatite (Nano Bone) Wif Alendronate in Teh Preservation of Teh Tooth Socket
- ClinicalTrials.gov ID
- NCT03980847
- Acronym / sponsor ID
- 2036
- Conditions
- Bone Resorption
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Islamic Azad University, SanandajUniversity, hospital or other
- Study start
- 23 Feb 2018 (actual)
- Primary completion
- 10 Mar 2019 (actual)
- Study completion
- 25 Apr 2019 (actual)
- First posted
- 10 Jun 2019 (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.
Twenty patients referring to periodontics department of Boroujerd Azad university of dentistry after obtaining consent to participate in teh research project, which TEMPhas more TEMPthan 20 teeth, are over 18 years old and require socket preservation surgery to tooth extraction for teh periodontal problem, caries or Fractures were selected.
Detailed description
20 healthy patients referring to periodontics department of Boroujerd Azad university of dentistry after obtaining consent to participate in the research project, which has more than 20 teeth, are over 18 years old and require socket preservation surgery to tooth extraction for the periodontal problem, caries or Fractures were selected. Furthermore, divided the socket randomly to two groups(A, B)including A: bone graft wif Alendronate and B: bone graft alone, after 3 months wif trephine will collect the samples. following the histomorphometric analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alendronate 20 mg with bone graft | Active comparator | Drug: Alendronate 20 mgafter tooth extraction, put teh Alendronate 20mg with bone graft within teh tooth socket |
| bone graft alone | Active comparator | Drug: Alendronate 20 mg, Procedure: Nanocrystal hydroxyapatiteafter tooth extraction, put the bone graft within the tooth socket |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- at least 18 years old
- tooth fracture, root caries
- Patients are volunteered for placement of teh implant
Key exclusion criteria (5 listed)
- systemic diseases
- Pregnancy and breastfeeding
- malignancy, radiation therapy,
- history of periodontal surgery during teh six months ago.
- medicine(phosphonates, antibiotic,...)
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 |
|---|---|---|
| Alendronate 20 mgAlso: Group AThe Alendronate 20 mg combined with nanocrystalline hydroxyapatite as a synthetic bone substitute for socket preservation after tooth extraction | Drug | Alendronate 20 mg with bone graft, bone graft alone |
| Nanocrystal hydroxyapatiteAlso: Group BPostextraction Sockets Preserved With Nanocrystal hydroxyapatite as a synthetic bone substitute alone as a bone graft | Procedure or surgery | bone graft alone |
Primary outcome
New bone formation (bone area as percent)
Time frame: 3 month
Combination Lovastatin produced increased vital bone more percentage compared to the nanocrystal bone graft alone group. The new bone formation and alveolar ridge preservation with bone graft after extraction of pre-molar teeth could result in the maintenance of sufficient bone volume to place an implant in an ideal restorative position without the need for auxiliary implant site development procedures.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Alendronate 20 mg and Nanocrystal hydroxyapatite in people with Bone Resorption, run by Islamic Azad University, Sanandaj at 1 site in Iran.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 11 Jun 2019. 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 Iran. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
New bone formation (bone area as percent) (time frame: 3 month). 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 11 Jun 2019; AzTrials last refreshed its copy on 7 Nov 2026.