Periodontitis (Stage 3)NCT05258006
Assessment of Autogenous Dentin Graft in Treatment of Infra-bony Defect
A study testing Autogenous demineralized dentin nanoparticles in people with Periodontitis (Stage 3), run by October 6 University at 1 site in Egypt.
Trial summary
The aim of the present study was to evaluate the effect of demineralized autogenous dentine on treatment of infrabony defects. Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- Periodontitis (Stage 3)
- What is being tested?
- Autogenous demineralized dentin nanoparticles
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 1 Jan 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 16 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with good systemic health and no contraindication for periodontal surgery.
- Patients who are able to maintain good oral hygiene.
- Gingival thickness for the site selected should be ≥1mm.
- Probing depth of ≥ 6mm.
- Patient has at least one hopeless teeth
Who cannot join
- Active infectious diseases (hepatitis, tubercu¬losis, HIV, etc….).
- Medically compromised patients.
- Smokers and alcoholic abusers
- People who suffer from any systemic disease that affect the periodontium.
- Pregnant, postmenopausal women.
- People who take anti-inflammatory drugs, anti¬biotics or vitamins within the previous 3 month.
- People who use mouth washes regularly
- Participants in other clinical trials.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Assessment of Autogenous Dentin Nanoparticles in Treatment of Stage III Periodontitis: A Split-Mouth Clinical Study
The aim of the present study was to evaluate the effect of demineralized autogenous dentine on treatment of infrabony defects.
Read the detailed description
In this study, the investigators tested the effect of demineralized autogenous dentine as a bone graft in treatment of stage III periodontitis in term of probing pocket depth reduction, mean gain in clinical attachment level, and bone gain in defect sites.
- Conditions
- Periodontitis (Stage 3)
- Being tested
- Autogenous demineralized dentin nanoparticles
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autogenous demineralized dentin nanoparticlesProcedure or surgery
Effect of Autogenous demineralized dentin nanoparticles in bone gain in infrabony defect
| Study group | Role | What they receive |
|---|---|---|
| Open flap debridement + allograft bone (Maxgraft) | Placebo comparator | Not described Receives: Procedure: Autogenous demineralized dentin nanoparticles |
| Open flap debridement + Autogenous demineralized nanoparticles | Active comparator | Not described Receives: Procedure: Autogenous demineralized dentin nanoparticles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vertical bone loss
vertical bone loss was measured from cementoenamel junction (CEJ) to the base of the bone defect in each site in group I \& II.
Measured: 6 months
Clinical attachment level
Clinical attachment level was measured at baseline and 6 months
Measured: 6 months
Probing pocket depth
Probing pocket depth was measured at baseline and 6 months
Measured: 6 months
Bone gain
The bone gain is calculated by:
- Preoperative VBL (at baseline): measured as the distance from cementoenamel junction (CEJ) to the base of the bone defect.
- Postoperative VBL (after 6 months) measured as the distance from cementoenamel junction (CEJ) to the base of the bone formation.
- Postoperative bone fill (bone gain after 6 months) [measured by subtracting the preoperative VBL from the postoperative VBL].
Measured: 6 months
Secondary outcomes (2)
Plaque Index
plaque index was measured at baseline, 3, 6 months
Measured: 6 months
Gingival index
Gingival index was measured at baseline, 3, 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start1 Jan 2021
- Primary completion1 Nov 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Periodontitis (Stage 3)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enas Elgendy, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05258006
- Sponsor's protocol ID
- 4
- Status last verified
- Feb 2022
- First submitted
- 10 Feb 2022
- Last updated
- 25 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Elgendy EA, Elgendy AM, ElBorady OM. Clinical And Radiographic Assessment Of Autogenous Dentin Nanoparticles In Treatment Of Stage Iii Periodontitis: A Split-Mouth Clinical Study. J Pak Med Assoc. 2023 Apr;73(Suppl 4)(4):S310-S316. doi: 10.47391/JPMA.EGY-S4-60.
PubMed 37482878
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Assessment of Autogenous Dentin Nanoparticles in Treatment of Stage III Periodontitis: A Split-Mouth Clinical Study
- ClinicalTrials.gov ID
- NCT05258006
- Acronym / sponsor ID
- 4
- Conditions
- Periodontitis (Stage 3)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 25 Feb 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 aim of the present study was to evaluate the effect of demineralized autogenous dentine on treatment of infrabony defects.
Detailed description
In this study, the investigators tested the effect of demineralized autogenous dentine as a bone graft in treatment of stage III periodontitis in term of probing pocket depth reduction, mean gain in clinical attachment level, and bone gain in defect sites.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open flap debridement + allograft bone (Maxgraft) | Placebo comparator | Procedure: Autogenous demineralized dentin nanoparticles |
| Open flap debridement + Autogenous demineralized nanoparticles | Active comparator | Procedure: Autogenous demineralized dentin nanoparticles |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patients with good systemic health and no contraindication for periodontal surgery.
- Patients who are able to maintain good oral hygiene.
- Gingival thickness for the site selected should be ≥1mm.
- Probing depth of ≥ 6mm.
- Patient has at least one hopeless teeth
Key exclusion criteria (8 listed)
- Active infectious diseases (hepatitis, tubercu¬losis, HIV, etc….).
- Medically compromised patients.
- Smokers and alcoholic abusers
- People who suffer from any systemic disease that affect the periodontium.
- Pregnant, postmenopausal women.
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 |
|---|---|---|
| Autogenous demineralized dentin nanoparticlesEffect of Autogenous demineralized dentin nanoparticles in bone gain in infrabony defect | Procedure or surgery | Open flap debridement + Autogenous demineralized nanoparticles, Open flap debridement + allograft bone (Maxgraft) |
Primary outcome
Vertical bone loss
Time frame: 6 months
vertical bone loss was measured from cementoenamel junction (CEJ) to the base of the bone defect in each site in group I \& II.
Clinical attachment level
Time frame: 6 months
Clinical attachment level was measured at baseline and 6 months
Probing pocket depth
Time frame: 6 months
Probing pocket depth was measured at baseline and 6 months
Bone gain
Time frame: 6 months
The bone gain is calculated by: * Preoperative VBL (at baseline): measured as the distance from cementoenamel junction (CEJ) to the base of the bone defect. * Postoperative VBL (after 6 months) measured as the distance from cementoenamel junction (CEJ) to the base of the bone formation. * Postoperative bone fill (bone gain after 6 months) [measured by subtracting the preoperative VBL from the postoperative VBL].
2 secondary outcomes
Plaque Index
Time frame: 6 months
Gingival index
Time frame: 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 25 Feb 2022.
- Derived from this study: PubMed 37482878Elgendy EA, Elgendy AM, ElBorady OM. Clinical And Radiographic Assessment Of Autogenous Dentin Nanoparticles In Treatment Of Stage Iii Periodontitis: A Split-Mouth Clinical Study. J Pak Med Assoc. 2023 Apr;73(Suppl 4)(4):S310-S316. doi: 10.47391/JPMA.EGY-S4-60.
- Individual participant dataSharing planned: Undecided
Related trials for Periodontitis (Stage 3)
RecruitingObservational study
Characterization of Small Intestinal Bacterial Overgrowth and Intestinal Barrier-Related Biomarkers in Patients With Severe Periodontitis
Periodontitis (Stage 3), Periodontitis Stage IV
Recruiting
A Clinical Trial Comparing 2x/Day for 30-minutes Use of the Emanate Perio PODS Post-SRP to a Control Group Post-SRP.
Periodontitis (Stage 3)
Active, not recruitingObservational study
Evaluation of the Effect of Smoking on Apelin, Periostin, and High-Sensitivity CRP Levels in Gingival Crevicular Fluid and Serum
Periodontitis (Stage 3), Periodontal Health
Recruiting
Active Oxygen Releasing Gel With Photodynamic Therapy in Treating Stage III Periodontitis
Stage III Periodontitis
Recruiting
Dental Loupe Versus Dental Operating Microscope for Non-Surgical Periodontal Treatment
Periodontitis, Periodontitis and Treatment Need
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 Autogenous demineralized dentin nanoparticles in people with Periodontitis (Stage 3), run by October 6 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 5 inclusion and 8 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 25 Feb 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?
Vertical bone loss (time frame: 6 months). The study lists 4 primary outcomes in all. 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 NCT05258006, which also lists 1 linked publication.
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 25 Feb 2022.