PeriodontitisPhase 2NCT06050174
Azadirachta Indica (Neem) Extract as an Adjunct to Non-Surgical Periodontal Management
A Phase 2 study testing Azadirachta Indica and Non Surgical Periodontal Therapy in people with Periodontitis, run by Ain Shams University at 1 site in Egypt.
Trial summary
Azadirachta-Indica has various therapeutic activities such as antiseptic, antiulcer, astringent, superior antiviral and for cleaning the teeth in various dental diseases in vitro and vivo. It also purifies blood, removes toxins from the body and neutralizes free radicals. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- Azadirachta Indica and Non Surgical Periodontal Therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2021to 1 Jul 2023
- 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 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Both males and females will be included in the age group of 20-55 years old.
- Patients diagnosed to have (Stage II or Stage III) periodontitis; (3-6 mm CAL, pocket depth ≤ 7 mm, mostly horizontal 15%-33% bone loss as assessed by preoperative radiographs with no tooth loss due to periodontitis).
- Patients free from systemic diseases according to the modified Burkett's health history questionnaire.
- Patients who can follow and maintain oral hygiene instructions.
- Patients who didn't perform any periodontal therapy in the last 6 months.
Who cannot join
- Pregnant ladies or lactating mothers.
- Smokers.
- Patients with history of allergy against one of the components of neem.
- Asthmatic patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Locally Delivered Azadirachta Indica (Neem) Extract as an Adjunct to Non-Surgical Periodontal Management
Azadirachta-Indica has various therapeutic activities such as antiseptic, antiulcer, astringent, superior antiviral and for cleaning the teeth in various dental diseases in vitro and vivo. It also purifies blood, removes toxins from the body and neutralizes free radicals. Due to its therapeutic effects, ease of availability of neem, being cost effective and its safety with no adverse reactions, Azadirachta-Indica has been selected for this study as a local drug delivery in the gel form to be placed in periodontal pockets as an adjunct to non-surgical periodontal debridement for the management of localized periodontitis.
Read the detailed description
Total number of thirty-two (32) periodontitis patients including both males and females will be included in the study.
To assess the effect of neem gel on the clinical parameters of patients with localized periodontitis t-test or an equivalent non-parametric test will be used for comparison of Intervention group (neem extract gel) and Control group (non-surgical periodontal debridement). At first preoperative periapical radiographs will be taken for assessment of bone level. The patients will receive full mouth one stage debridement using ultrasonic scalers, manual scalers and curettes with oral hygiene instructions and education.
Baseline assessment will be done following phase I therapy by 2 weeks by full mouth periodontal charting and samples from gingival crevicular fluid will be taken using a sterile perio-paper inserted into the deepest periodontal pocket with horizontal bone loss. AzadirachtaIndica Extract Gel will be applied in the deepest pocket by syringe with blunted tip gently and removed slowly in order not to harm the tissue for group 1 patients after phase 1 therapy by two weeks. Follow up of the patients will be done after 3 months after phase I therapy with evaluation of the clinical parameters. The patients will be instructed to brush their teeth 3 times per day during the treatment period using a soft tooth brush together with regular flossing of teeth. A brochure containing written oral hygiene instructions will be given to the patients.
The clinical parameters will be measured two times during the study, the first time at the baseline after two weeks of full mouth debridement and the second time is after baseline by 3 months.
GCF sampling will be done just before neem gel application. Mean values of each parameter will be calculated per patient and per group as well as parameters at the deepest pocket site.
A full mouth periodontal charting will be performed.
- Conditions
- Periodontitis
- Being tested
- Azadirachta Indica, Non Surgical Periodontal Therapy
- Keywords
- Periodontitis, Azadirachta Indica, Locally Delivery, TNF-α
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azadirachta IndicaDrug
Also called Neem, Nimba, Vembu, Arishtha
Azadirachtaindica L. is a multipurpose medicinal tree of family Meliaceae.Is also named "Nimba", "holy tree", "Vembu", "Arishtha", "Indian neem tree", "Indian lilac", "wonder tree. It occurs in tropical and semitropical regions of the world. Almost all parts of this incredible tree have been used as phytomedicines for more than 4,000 years.
Various pharmacological attributes such as antifungal, antiviral, antibacterial, anti-inflammatory, sterilant, antiscabic, antiallergenic and analgesic are attributed to various parts of the tree.
Non Surgical Periodontal TherapyProcedure or surgery
Also called Periodontal Debridement
The patients will receive full mouth one stage debridement using ultrasonic scalers, manual scalers and curettes with oral hygiene instructions and education.
| Study group | Role | What they receive |
|---|---|---|
| Azadirachta Indica | Experimental | Azadirachta Indica (neem) gel are locally delivered to deepest part of the periodontal pocket by syringe with blunted tip gently and removed slowly in order not to harm the tissue for group 1 patients after phase 1 therapy by two weeks. Receives: Drug: Azadirachta Indica; Procedure: Non Surgical Periodontal Therapy |
| Non Surgical Periodontal Therapy | Placebo comparator | The patients will receive full mouth one stage debridement using ultrasonic scalers, manual scalers and curettes with oral hygiene instructions and education. Receives: Procedure: Non Surgical Periodontal Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical score
Measuring plaque index, Modified sulcus bleeding index, Probing depth, 4. Clinical attachment level.
Measured: change from baseline at 3 months
Secondary outcomes (1)
Tumor Necrosis Factor alpha
Measuring concentrations of Tumor Necrosis Factor (TNF-α).
Measured: change from baseline at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start1 Sep 2021
- Primary completion15 Apr 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hala A. Abuel-Ela, Professor, Study director, Faculty of dentistry- Ain shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06050174
- Sponsor's protocol ID
- FDASU-RECD962
- Status last verified
- Sep 2023
- First submitted
- 17 Sep 2023
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Locally Delivered Azadirachta Indica (Neem) Extract as an Adjunct to Non-Surgical Periodontal Management
- ClinicalTrials.gov ID
- NCT06050174
- Acronym / sponsor ID
- FDASU-RECD962
- Conditions
- Periodontitis
- Keywords
- Periodontitis, Azadirachta Indica, Locally Delivery, TNF-α
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 15 Apr 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 22 Sep 2023 (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.
Azadirachta-Indica has various therapeutic activities such as antiseptic, antiulcer, astringent, superior antiviral and for cleaning the teeth in various dental diseases in vitro and vivo. It also purifies blood, removes toxins from the body and neutralizes free radicals. Due to its therapeutic effects, ease of availability of neem, being cost effective and its safety with no adverse reactions, Azadirachta-Indica has been selected for this study as a local drug delivery in the gel form to be placed in periodontal pockets as an adjunct to non-surgical periodontal debridement for the management of localized periodontitis.
Detailed description
Total number of thirty-two (32) periodontitis patients including both males and females will be included in the study.
To assess the effect of neem gel on the clinical parameters of patients with localized periodontitis t-test or an equivalent non-parametric test will be used for comparison of Intervention group (neem extract gel) and Control group (non-surgical periodontal debridement). At first preoperative periapical radiographs will be taken for assessment of bone level. The patients will receive full mouth one stage debridement using ultrasonic scalers, manual scalers and curettes with oral hygiene instructions and education.
Baseline assessment will be done following phase I therapy by 2 weeks by full mouth periodontal charting and samples from gingival crevicular fluid will be taken using a sterile perio-paper inserted into the deepest periodontal pocket with horizontal bone loss. AzadirachtaIndica Extract Gel will be applied in the deepest pocket by syringe with blunted tip gently and removed slowly in order not to harm the tissue for group 1 patients after phase 1 therapy by two weeks. Follow up of the patients will be done after 3 months after phase I therapy with evaluation of the clinical parameters. The patients will be instructed to brush their teeth 3 times per day during the treatment period using a soft tooth brush together with regular flossing of teeth. A brochure containing written oral hygiene instructions will be given to the patients.
The clinical parameters will be measured two times during the study, the first time at the baseline after two weeks of full mouth debridement and the second time is after baseline by 3 months.
GCF sampling will be done just before neem gel application. Mean values of each parameter will be calculated per patient and per group as well as parameters at the deepest pocket site.
A full mouth periodontal charting will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Azadirachta Indica | Experimental | Drug: Azadirachta Indica, Procedure: Non Surgical Periodontal TherapyAzadirachta Indica (neem) gel are locally delivered to deepest part of the periodontal pocket by syringe with blunted tip gently and removed slowly in order not to harm the tissue for group 1 patients after phase 1 therapy by two weeks. |
| Non Surgical Periodontal Therapy | Placebo comparator | Procedure: Non Surgical Periodontal TherapyThe patients will receive full mouth one stage debridement using ultrasonic scalers, manual scalers and curettes with oral hygiene instructions and education. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Both males and females will be included in the age group of 20-55 years old.
- Patients diagnosed to have (Stage II or Stage III) periodontitis; (3-6 mm CAL, pocket depth ≤ 7 mm, mostly horizontal 15%-33% bone loss as assessed by preoperative radiographs with no tooth loss due to periodontitis).
- Patients free from systemic diseases according to the modified Burkett's health history questionnaire.
- Patients who can follow and maintain oral hygiene instructions.
- Patients who didn't perform any periodontal therapy in the last 6 months.
Key exclusion criteria (4 listed)
- Pregnant ladies or lactating mothers.
- Smokers.
- Patients with history of allergy against one of the components of neem.
- Asthmatic patients
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 |
|---|---|---|
| Azadirachta IndicaAlso: Neem, Nimba, Vembu, ArishthaAzadirachtaindica L. is a multipurpose medicinal tree of family Meliaceae.Is also named "Nimba", "holy tree", "Vembu", "Arishtha", "Indian neem tree", "Indian lilac", "wonder tree. It occurs in tropical and semitropical regions of the world. Almost all parts of this incredible tree have been used as phytomedicines for more than 4,000 years. Various pharmacological attributes such as antifungal, antiviral, antibacterial, anti-inflammatory, sterilant, antiscabic, antiallergenic and analgesic are attributed to various parts of the tree. | Drug | Azadirachta Indica |
| Non Surgical Periodontal TherapyAlso: Periodontal DebridementThe patients will receive full mouth one stage debridement using ultrasonic scalers, manual scalers and curettes with oral hygiene instructions and education. | Procedure or surgery | Azadirachta Indica, Non Surgical Periodontal Therapy |
Primary outcome
clinical score
Time frame: change from baseline at 3 months
Measuring plaque index, Modified sulcus bleeding index, Probing depth, 4. Clinical attachment level.
1 secondary outcome
Tumor Necrosis Factor alpha
Time frame: change from baseline at 3 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 22 Sep 2023.
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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.
Hala A. Abuel-Ela, Professor study director
Faculty of dentistry- Ain shams University
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 Azadirachta Indica and Non Surgical Periodontal Therapy in people with Periodontitis, run by Ain Shams 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 4 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 22 Sep 2023. 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.
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?
clinical score (time frame: change from baseline at 3 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 22 Sep 2023.