Chronic PeriodontitisNCT02507596
Evaluation of Nano-crystalline Hydroxyapatite Silica Gel in Management of Periodontal Intrabony Defects
A study testing Nano-crystalline hydroxyapatite silica gel and open flap debridement in people with Chronic Periodontitis, run by Cairo University at 1 site in Egypt.
Trial summary
A clinical and radiographic evaluation of Nano-crystalline hydroxyapatite silica gel in comparison with open flap debridement for management of periodontal intrabony defects. Read more about this study
- Who is it for?
- Ages 35 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- Nano-crystalline hydroxyapatite silica gel and open flap debridement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2015to Dec 2019
- 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 35 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Severe chronic periodontitis patients.
- having at least one site with pocket depth ≥ 6 mm and clinical attachment level ≥ 5 mm, with radiographic evidence of bone loss as detected in periapical radiographs.
Who cannot join
- Pregnant women
- Subjects had <22 permanent teeth
- Having any given systemic disease
- Taking any type of medication and/or antibiotic therapy during the 3 months before the study
- Received periodontal treatment within the past 12 months Current or former smokers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Evaluation of Nano-crystalline Hydroxyapatite Silica Gel in the Treatment of Human Periodontal Intrabony Defects
A clinical and radiographic evaluation of Nano-crystalline hydroxyapatite silica gel in comparison with open flap debridement for management of periodontal intrabony defects.
Read the detailed description
Thirty patients suffering from advanced chronic periodontitis were included in this randomized controlled clinical trial. Each subject contributed matched two- or three-walled intrabony defects. Patients were equally assigned into the experimental group; Nano-crystalline hydroxyapatite silica gel or the negative control group;open flap debridement. Clinical and radiographic parameters were recorded at baseline and at 3 and 6 months postoperatively.
- Conditions
- Chronic Periodontitis
- Being tested
- Nano-crystalline hydroxyapatite silica gel, open flap debridement
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nano-crystalline hydroxyapatite silica gelBiological
Also called Nanobone
it is a type of synthetic bone graft.
open flap debridementProcedure or surgery
Also called OFD
a periodontal surgical procedure for the purpose of debridement.
| Study group | Role | What they receive |
|---|---|---|
| Nano-crystalline hydroxyapatite silica gel | Experimental | hydroxyapaptite bone graft with nano particle size in silica gel will be used to fill in the defect after opening a periodontal flap Receives: Biological: Nano-crystalline hydroxyapatite silica gel |
| Open flap debridement | Sham comparator | an open periodontal flap without adding bone graft. Receives: Procedure: open flap debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical attachment level
Change from baseline in clinical attachment level in mm in chronic periodontitis patients at 6 month
Measured: change from Baseline at 6 months
Secondary outcomes (2)
pocket depth
Estimation of pocket depth in mm in chronic periodontitis patients at baseline and 6 months
Measured: Baseline and 6 months
bone defect area
Estimation of bone fill defect area in mm square in chronic periodontitis patients at baseline and 6 month
Measured: Baseline 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 posted24 Jul 2015 (estimated)
- Study startApr 2015
- Primary completionOct 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic PeriodontitisStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Ayman Ghallab, Cairo University
- Investigators
- Weam Battawy, MD, Study chair, Lecturer of Oral Medicine and PeriodontologyNoha Ghallab, MD, Principal investigator, Associate Professor of Oral Medicine and PeriodontologyDalia AbdelHamid, MD, Study director, Associate Professor of BiomaterialsRiham Hamdy, MD, Study chair, Associate Professor of Oral and Maxillofacial Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02507596
- Sponsor's protocol ID
- Nanobone_IBD
- Status last verified
- Mar 2022
- First submitted
- 13 Jul 2015
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Reynolds MA, Aichelmann-Reidy ME, Branch-Mays GL, Gunsolley JC. The efficacy of bone replacement grafts in the treatment of periodontal osseous defects. A systematic review. Ann Periodontol. 2003 Dec;8(1):227-65. doi: 10.1902/annals.2003.8.1.227.
PubMed 14971256Heinz B, Kasaj A, Teich M, Jepsen S. Clinical effects of nanocrystalline hydroxyapatite paste in the treatment of intrabony periodontal defects: a randomized controlled clinical study. Clin Oral Investig. 2010 Oct;14(5):525-31. doi: 10.1007/s00784-009-0325-x. Epub 2009 Aug 13.
PubMed 19680697Kasaj A, Rohrig B, Zafiropoulos GG, Willershausen B. Clinical evaluation of nanocrystalline hydroxyapatite paste in the treatment of human periodontal bony defects--a randomized controlled clinical trial: 6-month results. J Periodontol. 2008 Mar;79(3):394-400. doi: 10.1902/jop.2008.070378.
PubMed 18315420
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Nano-crystalline Hydroxyapatite Silica Gel in the Treatment of Human Periodontal Intrabony Defects
- ClinicalTrials.gov ID
- NCT02507596
- Acronym / sponsor ID
- Nanobone_IBD
- Conditions
- Chronic Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Oct 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 24 Jul 2015 (estimated)
- 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.
A clinical and radiographic evaluation of Nano-crystalline hydroxyapatite silica gel in comparison with open flap debridement for management of periodontal intrabony defects.
Detailed description
Thirty patients suffering from advanced chronic periodontitis were included in this randomized controlled clinical trial. Each subject contributed matched two- or three-walled intrabony defects. Patients were equally assigned into the experimental group; Nano-crystalline hydroxyapatite silica gel or the negative control group;open flap debridement. Clinical and radiographic parameters were recorded at baseline and at 3 and 6 months postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nano-crystalline hydroxyapatite silica gel | Experimental | Biological: Nano-crystalline hydroxyapatite silica gelhydroxyapaptite bone graft with nano particle size in silica gel will be used to fill in the defect after opening a periodontal flap |
| Open flap debridement | Sham comparator | Procedure: open flap debridementan open periodontal flap without adding bone graft. |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Severe chronic periodontitis patients.
- having at least one site with pocket depth ≥ 6 mm and clinical attachment level ≥ 5 mm, with radiographic evidence of bone loss as detected in periapical radiographs.
Key exclusion criteria (5 listed)
- Pregnant women
- Subjects had <22 permanent teeth
- Having any given systemic disease
- Taking any type of medication and/or antibiotic therapy during the 3 months before the study
- Received periodontal treatment within the past 12 months Current or former smokers
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 |
|---|---|---|
| Nano-crystalline hydroxyapatite silica gelAlso: Nanoboneit is a type of synthetic bone graft. | Biological | Nano-crystalline hydroxyapatite silica gel |
| open flap debridementAlso: OFDa periodontal surgical procedure for the purpose of debridement. | Procedure or surgery | Open flap debridement |
Primary outcome
Clinical attachment level
Time frame: change from Baseline at 6 months
Change from baseline in clinical attachment level in mm in chronic periodontitis patients at 6 month
2 secondary outcomes
pocket depth
Time frame: Baseline and 6 months
bone defect area
Time frame: Baseline and 6 months
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 Mar 2022.
- Background: PubMed 14971256Reynolds MA, Aichelmann-Reidy ME, Branch-Mays GL, Gunsolley JC. The efficacy of bone replacement grafts in the treatment of periodontal osseous defects. A systematic review. Ann Periodontol. 2003 Dec;8(1):227-65. doi: 10.1902/annals.2003.8.1.227.
- Background: PubMed 19680697Heinz B, Kasaj A, Teich M, Jepsen S. Clinical effects of nanocrystalline hydroxyapatite paste in the treatment of intrabony periodontal defects: a randomized controlled clinical study. Clin Oral Investig. 2010 Oct;14(5):525-31. doi: 10.1007/s00784-009-0325-x. Epub 2009 Aug 13.
- Background: PubMed 18315420Kasaj A, Rohrig B, Zafiropoulos GG, Willershausen B. Clinical evaluation of nanocrystalline hydroxyapatite paste in the treatment of human periodontal bony defects--a randomized controlled clinical trial: 6-month results. J Periodontol. 2008 Mar;79(3):394-400. doi: 10.1902/jop.2008.070378.
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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.
Weam Battawy, MD study chair
Lecturer of Oral Medicine and Periodontology
Noha Ghallab, MD principal investigator
Associate Professor of Oral Medicine and Periodontology
Dalia AbdelHamid, MD study director
Associate Professor of Biomaterials
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nano-crystalline hydroxyapatite silica gel and open flap debridement in people with Chronic Periodontitis, run by Cairo 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 2 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 Mar 2022. 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. 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.
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?
Clinical attachment level (time frame: change from Baseline at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02507596, which also lists 3 linked publications.
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 Mar 2022; AzTrials last refreshed its copy on 8 Nov 2026.