Effects of the ElementsNCT05100615
Healing Assessment of Osseous Defects After Surgical Removal of Periapical Lesions
A study testing surgery in people with Effects of the Elements, run by Minia University at 1 site in Egypt.
Trial summary
recruited patients with periapical lesions will be divided into three groups and surgically treated with three types of bone graft (hydroxyappatite, nanohydroxyappatite and PRF WITH NANOHYDROXTAPPATITE) and then evaluated for month, three months and six months for the healing of periapical bone Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Effects of the Elements
- What is being tested?
- surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2021to May 2022
- Phase
- Interventional
- 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The patient will be in range of 20-45 years of age at the time of treatment, having periapical lesions starting from 5mm or more in diameter related to failed endodontically treated single canaled teeth.
Who cannot join
- Any systemic debilitating disease such as:
- Diabetes mellitus, renal disease, Liver disease or liver failure, Rheumatoid arthritis, Neoplastic disease or its treatment, chronic corticosteroid therapy, chronic hepatitis B or C , History of hepatitis A, pregnant females.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Amira mohammed fathy Elkholly
Cairo
Amira Elkholly, PHD, 01001902507, dr.amiraelkholly@yahoo.com
Reham Hassan, Ass.prof, 01001542529, reham-hassan@live.com
About this study
Official title: Healing Assessment of Osseous Defects After Surgical Removal of Periapical Lesions in the Presence of Hydroxyapatite, Nanohydroxyapatite and Combination of Nanohydroxyapatite and Platelet-rich Fibrin. A Clinical Study
recruited patients with periapical lesions will be divided into three groups and surgically treated with three types of bone graft (hydroxyappatite, nanohydroxyappatite and PRF WITH NANOHYDROXTAPPATITE) and then evaluated for month, three months and six months for the healing of periapical bone
- Conditions
- Effects of the Elements
- Being tested
- surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgeryProcedure or surgery
applying the graft inside bony defect after surgery
| Study group | Role | What they receive |
|---|---|---|
| hydroxyappatite | Other | hydroxyapatite powder used for enhancement of bone regeneration Receives: Procedure: surgery |
| nanohydroxyapatite | Other | nanohydroxyapatite powder used for enhancement of bone regeneration Receives: Procedure: surgery |
| PRF with nanohydroxyapatite | Other | platelet rich fibrin mixed with nanohydroxyapatite used for enhancement of bone regeneration Receives: Procedure: surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
healing of periapical lesion
change in size of bony defect
Measured: interappointment at 1 month, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study startNov 2021 (estimated)
- Primary completionMay 2022 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effects of the ElementsStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira mohammed elkholly, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05100615
- Sponsor's protocol ID
- 238
- Status last verified
- Oct 2021
- First submitted
- 28 Sep 2021
- Last updated
- 29 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healing Assessment of Osseous Defects After Surgical Removal of Periapical Lesions in the Presence of Hydroxyapatite, Nanohydroxyapatite and Combination of Nanohydroxyapatite and Platelet-rich Fibrin. A Clinical Study
- ClinicalTrials.gov ID
- NCT05100615
- Acronym / sponsor ID
- 238
- Conditions
- Effects of the Elements
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- Nov 2021 (estimated)
- Primary completion
- May 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 29 Oct 2021 (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.
recruited patients with periapical lesions will be divided into three groups and surgically treated with three types of bone graft (hydroxyappatite, nanohydroxyappatite and PRF WITH NANOHYDROXTAPPATITE) and then evaluated for month, three months and six months for the healing of periapical bone
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| hydroxyappatite | Other | Procedure: surgeryhydroxyapatite powder used for enhancement of bone regeneration |
| nanohydroxyapatite | Other | Procedure: surgerynanohydroxyapatite powder used for enhancement of bone regeneration |
| PRF with nanohydroxyapatite | Other | Procedure: surgeryplatelet rich fibrin mixed with nanohydroxyapatite used for enhancement of bone regeneration |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The patient will be in range of 20-45 years of age at the time of treatment, having periapical lesions starting from 5mm or more in diameter related to failed endodontically treated single canaled teeth.
Key exclusion criteria (2 listed)
- Any systemic debilitating disease such as:
- Diabetes mellitus, renal disease, Liver disease or liver failure, Rheumatoid arthritis, Neoplastic disease or its treatment, chronic corticosteroid therapy, chronic hepatitis B or C , History of hepatitis A, pregnant females.
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 |
|---|---|---|
| surgeryapplying the graft inside bony defect after surgery | Procedure or surgery | PRF with nanohydroxyapatite, hydroxyappatite, nanohydroxyapatite |
Primary outcome
healing of periapical lesion
Time frame: interappointment at 1 month, 3 months and 6 months
change in size of bony defect
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
- Individual participant dataSharing planned: Yes
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surgery in people with Effects of the Elements, run by Minia University at 1 site in Egypt.
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 1 inclusion and 2 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 29 Oct 2021. 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 Egypt. 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.
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?
Contact Amira Elkholly, PHD (+201001902507 ext. Egypt, dr.amiraelkholly@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
healing of periapical lesion (time frame: interappointment at 1 month, 3 months and 6 months). 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 29 Oct 2021.