Chronic PeriodontitisNCT04643288
Nanocrystalline Hydroxyapatite Bone Substitute for Treating Periodontal Intrabony Defects
A study testing open flap debridement and n-HA bone graft in people with Chronic Periodontitis, run by Weam Ahmed Elbattawy at 1 site in Egypt.
Trial summary
The present clinical trial included 20 patients (11 females and 9 males, aged 36 to 56 years) suffering from moderate or advanced chronic periodontitis. Subjects were recruited from the outpatient clinic, Department of Oral Medicine and Periodontology, Faculty of Dentistry, Cairo University. Read more about this study
- Who is it for?
- Ages 35 to 56 years
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- open flap debridement and n-HA bone graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2018to 25 May 2020
- 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 56 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- systemically healthy patients
- diagnosed with moderate to advanced chronic periodontitis
- periodontal defects with at least one site with probing pocket depth (PPD) ≥ 5mm, clinical attachment loss (CAL) ≥ 4mm and two or three-walled intra-bony defects ≥ 3mm
- evidence of intrabony defects using periapical radiographs
Who cannot join
- teeth with suprabony defects or 1-wall intrabony defects
- pregnant or lactating women
- patients taking any medication 3 months prior to the study
- patients receiving any periodontal treatment 6 months prior to study initiation
- former or current smokers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Evaluation of Open Flap Debridement With or Without Nanocrystalline Hydroxyapatite Bone Graft in Management of Periodontal Intrabony Defects
The present clinical trial included 20 patients (11 females and 9 males, aged 36 to 56 years) suffering from moderate or advanced chronic periodontitis. Subjects were recruited from the outpatient clinic, Department of Oral Medicine and Periodontology, Faculty of Dentistry, Cairo University. This clinical trial was meant to assess clinically and radiographically the possible predictable results regarding the use of nanocrystalline hydroxyapatite bone graft substitute together with open flap debridement versus open flap debridement alone in the treatment of periodontal intrabony defects.
Read the detailed description
periodontal intrabony defects in patients with moderate or advanced chronic periodontitis were treated with open flap debridement only in the control group while open flap debridement and Nanocrystalline Hydroxyapatite bone graft substitute was performed for the intervention group. probing pocket depth, clinical attachment level, gingival index, plaque index, gingival recession and bone defect area were assessed at baseline and six months post surgically to evaluate the possible improvement in the clinical and radiographic outcomes.
- Conditions
- Chronic Periodontitis
- Being tested
- open flap debridement, n-HA bone graft
- Keywords
- periodontal intrabony defects
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
open flap debridementProcedure or surgery
open flap debridement for managing two and three walls intrabony periodontal defects
n-HA bone graftProcedure or surgery
Nanocrystalline Hydroxyapatite bone graft substitute for managing two and three walls intrabony periodontal defects
| Study group | Role | What they receive |
|---|---|---|
| OFD control group | Experimental | open flap debridement for periodontal intrabony defects Receives: Procedure: open flap debridement |
| n-HA bone graft intervention group | Experimental | Nanocrystalline Hydroxyapatite (n-HA) bone graft substitute was added to periodontal intrabony defects Receives: Procedure: open flap debridement; Procedure: n-HA bone graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in probing pocket depth
William's graduated periodontal probe used to measure probing pocket depth from the gingival margin to the base of the sulcus
Measured: baseline and after six months
Secondary outcomes (2)
change in clinical attachment level
William's graduated periodontal probe used to measure clinical attachment level from the cementoenamel junction to the base of the sulcus
Measured: baseline and after six months
change in the bone defect area
periodical digital radiographs using Digora software to measure the bone defect area
Measured: baseline and after six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start1 Sep 2018
- Primary completion25 Nov 2019
- Study completion25 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PeriodontitisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weam Ahmed Elbattawy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Weam Ahmed Elbattawy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04643288
- Sponsor's protocol ID
- nano version 1
- Status last verified
- Nov 2020
- First submitted
- 14 Nov 2020
- Last updated
- 27 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Open Flap Debridement With or Without Nanocrystalline Hydroxyapatite Bone Graft in Management of Periodontal Intrabony Defects
- ClinicalTrials.gov ID
- NCT04643288
- Acronym / sponsor ID
- nano version 1
- Conditions
- Chronic Periodontitis
- Keywords
- periodontal intrabony defects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Weam Ahmed ElbattawyUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 25 Nov 2019 (actual)
- Study completion
- 25 May 2020 (actual)
- First posted
- 25 Nov 2020 (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 present clinical trial included 20 patients (11 females and 9 males, aged 36 to 56 years) suffering from moderate or advanced chronic periodontitis. Subjects were recruited from the outpatient clinic, Department of Oral Medicine and Periodontology, Faculty of Dentistry, Cairo University. This clinical trial was meant to assess clinically and radiographically the possible predictable results regarding the use of nanocrystalline hydroxyapatite bone graft substitute together with open flap debridement versus open flap debridement alone in the treatment of periodontal intrabony defects.
Detailed description
periodontal intrabony defects in patients with moderate or advanced chronic periodontitis were treated with open flap debridement only in the control group while open flap debridement and Nanocrystalline Hydroxyapatite bone graft substitute was performed for the intervention group. probing pocket depth, clinical attachment level, gingival index, plaque index, gingival recession and bone defect area were assessed at baseline and six months post surgically to evaluate the possible improvement in the clinical and radiographic outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OFD control group | Experimental | Procedure: open flap debridementopen flap debridement for periodontal intrabony defects |
| n-HA bone graft intervention group | Experimental | Procedure: open flap debridement, Procedure: n-HA bone graftNanocrystalline Hydroxyapatite (n-HA) bone graft substitute was added to periodontal intrabony defects |
Who may qualify
- Ages
- 35 to 56 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- systemically healthy patients
- diagnosed with moderate to advanced chronic periodontitis
- periodontal defects with at least one site with probing pocket depth (PPD) ≥ 5mm, clinical attachment loss (CAL) ≥ 4mm and two or three-walled intra-bony defects ≥ 3mm
- evidence of intrabony defects using periapical radiographs
Key exclusion criteria (5 listed)
- teeth with suprabony defects or 1-wall intrabony defects
- pregnant or lactating women
- patients taking any medication 3 months prior to the study
- patients receiving any periodontal treatment 6 months prior to study initiation
- former or current 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 |
|---|---|---|
| open flap debridementopen flap debridement for managing two and three walls intrabony periodontal defects | Procedure or surgery | OFD control group, n-HA bone graft intervention group |
| n-HA bone graftNanocrystalline Hydroxyapatite bone graft substitute for managing two and three walls intrabony periodontal defects | Procedure or surgery | n-HA bone graft intervention group |
Primary outcome
change in probing pocket depth
Time frame: baseline and after six months
William's graduated periodontal probe used to measure probing pocket depth from the gingival margin to the base of the sulcus
2 secondary outcomes
change in clinical attachment level
Time frame: baseline and after six months
change in the bone defect area
Time frame: baseline and after six 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 27 Nov 2020.
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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 study testing open flap debridement and n-HA bone graft in people with Chronic Periodontitis, run by Weam Ahmed Elbattawy 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 4 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 27 Nov 2020. 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?
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?
change in probing pocket depth (time frame: baseline and after six 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 27 Nov 2020.