Periodontal DiseasesNCT07697209
Adjunctive Antioxidant Effect of Centella Asiatica Nanoemulsion Gel in Management of Periodontitis
A study testing Centella asiatica nanoemulsion gel and Scaling and Root Planing (SRP) in people with Periodontal Diseases and Periodontal Bone Loss, run by Mansoura University at 1 site in Egypt.
Trial summary
The aims of the current study are: 1. Evaluation of the clinical efficacy of local delivery of nanoemulsion gel containing Centella asiatica extract as an adjunct to conventional non-surgical periodontal therapy in periodontitis patients. 2. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Periodontal Bone Loss
- What is being tested?
- Centella asiatica nanoemulsion gel and Scaling and Root Planing (SRP)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Mar 2025to 8 Sep 2025
- 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 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 25-55 years, either sex
- Diagnosis of periodontal health OR Stage III periodontitis (per 2017 World Workshop Classification)
Who cannot join
- Known allergy or sensitivity to any component of the study medication
- Systemic antibiotics or anti-inflammatory medications within the preceding 6 months
- Uncontrolled diabetes mellitus
- Cardiovascular disease
- Rheumatoid arthritis
- Renal disease
Show all 12Show fewer
- Pulmonary disease
- Thyroid disease
- Malignancy
- Current smokers
- Pregnant or lactating women
- Unable or unwilling to comply with prescribed oral hygiene instructions
Trial locations and contacts
1 site in 1 country.
Egypt1 site
faculty of dentistry Mansoura university, Mansoura, 35516
Al Mansurah
About this study
Official title: Adjunctive Antioxidant Effect of Centella Asiatica Nanoemulsion Gel in the Management of Periodontitis
The aims of the current study are:
- Evaluation of the clinical efficacy of local delivery of nanoemulsion gel containing Centella asiatica extract as an adjunct to conventional non-surgical periodontal therapy in periodontitis patients.
- Evaluation of the antioxidant effect of this treatment by the assessment of nuclear factor erythroid 2-related factor 2 (NrF2) and glutathione peroxidase 1 (GPX1) in the gingival crevicular fluid (GCF) samples.
Read the detailed description
Forty-five healthy patients with periodontitis and healthy subjects with healthy periodontium will be included in the current study. At the beginning of the treatment, all selected patients will be motivated about the benefit of plaque control and periodontal prophylaxis.
The participants will be selected from the Outpatient Clinic of the Department of Oral Medicine and Periodontology, Faculty of Dentistry, Mansoura University. The patients will be informed about the treatment that they will receive and steps that will be taken. This includes the possible effects or risks and other treatment options according to the rules of the ethical committee of the Faculty of Dentistry, Mansoura University. The subjects must understand this explanation in broad terms. They must be legally competent to give written consent before performing any required steps. The research protocol will be presented to the ethical committee at the Faculty of Dentistry, Mansoura University, to get its approval.
- Conditions
- Periodontal Diseases, Periodontal Bone Loss
- Being tested
- Centella asiatica nanoemulsion gel, Scaling and Root Planing (SRP)
- Keywords
- drug delivery, Centella Asiatica Nanoemulsion
- Medical subject headings
- Periodontal Diseases, Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Centella asiatica nanoemulsion gelDrug
Following scaling and root planing, patients in Group 1 received local subgingival application of Centella asiatica nanoemulsion gel via disposable syringe with a blunt-ended cannula, applied once weekly for 3 months.
Scaling and Root Planing (SRP)Procedure or surgery
Full-mouth scaling and root planing using ultrasonic instrumentation and Gracey curettes, plus standardized oral hygiene instructions.
| Study group | Role | What they receive |
|---|---|---|
| group I treated with C. asiatica nanoemulsion as an adjunct to SRP | Experimental | Group I (study group): 15 Patients with periodontitis Stage III will be treated with C. asiatica nanoemulsion as an adjunct to SRP. Receives: Drug: Centella asiatica nanoemulsion gel; Procedure: Scaling and Root Planing (SRP) |
| Group II (positive control group) treated with SRP | Active comparator | Group II (positive control): 15 patients with periodontitis Stage III will be treated with scaling and root planing (SRP) alone, with no adjunctive gel application. Receives: Procedure: Scaling and Root Planing (SRP) |
| Group III (negative control group): no intervention | No intervention | Group III (negative control/healthy control): 15 periodontally healthy participants who will receive no active periodontal intervention; assessed at baseline only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque Index
Full-mouth plaque accumulation scored at the mesial, distal, buccal, and lingual/palatal surfaces of each examined tooth on a 0-3 scale, with higher scores indicating greater plaque accumulation. The participant-level score is the average of all recorded surface scores.
Measured: Baseline and 3 months (Groups 1 and 2); baseline only (Group 3)
Gingival Index
Gingival inflammation was scored at each examined surface on a 0-3 scale based on gingival color, consistency, and presence/absence of bleeding on probing, with higher scores indicating more severe inflammation (0 = clinically healthy gingiva, 3 = severe inflammation with marked redness, edema, ulceration, or spontaneous bleeding).
Measured: Baseline and 3 months (Groups 1 and 2); baseline only (Group 3)
Gingival Bleeding Index
Presence or absence of bleeding recorded following gentle probing of the gingival margin at each examined site, calculated as the number of bleeding sites divided by the total number of examined sites and expressed as a percentage. Higher percentages indicate greater gingival bleeding.
Measured: Baseline and 3 months (Groups 1 and 2); baseline only (Group 3)
Periodontal Probing Depth (PPD)
Distance in millimeters from the free gingival margin to the base of the periodontal pocket, measured at multiple sites per tooth using a calibrated periodontal probe. Higher values indicate deeper pockets and greater periodontal destruction.
Measured: Baseline and 3 months (Groups 1 and 2); baseline only (Group 3)
Clinical Attachment Level (CAL)
Distance in millimeters from the cemento-enamel junction to the base of the periodontal pocket, measured at multiple sites per tooth using a calibrated periodontal probe. Higher values indicate greater loss of periodontal attachment
Measured: Baseline and 3 months (Groups 1 and 2); baseline only (Group 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start21 Mar 2025
- Primary completion8 Sep 2025
- Study completion8 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Majed M Alshammari, bachelor, Principal investigator, faculty of dentistry Mansoura university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07697209
- Sponsor's protocol ID
- M0602025OM
- Status last verified
- Jul 2026
- First submitted
- 18 Jan 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Antioxidant Effect of Centella Asiatica Nanoemulsion Gel in the Management of Periodontitis
- ClinicalTrials.gov ID
- NCT07697209
- Acronym / sponsor ID
- M0602025OM
- Conditions
- Periodontal Diseases, Periodontal Bone Loss
- Keywords
- drug delivery, Centella Asiatica Nanoemulsion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 21 Mar 2025 (actual)
- Primary completion
- 8 Sep 2025 (actual)
- Study completion
- 8 Sep 2025 (actual)
- First posted
- 13 Jul 2026 (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 aims of the current study are:
- Evaluation of the clinical efficacy of local delivery of nanoemulsion gel containing Centella asiatica extract as an adjunct to conventional non-surgical periodontal therapy in periodontitis patients.
- Evaluation of the antioxidant effect of this treatment by the assessment of nuclear factor erythroid 2-related factor 2 (NrF2) and glutathione peroxidase 1 (GPX1) in the gingival crevicular fluid (GCF) samples.
Detailed description
Forty-five healthy patients with periodontitis and healthy subjects with healthy periodontium will be included in the current study. At the beginning of the treatment, all selected patients will be motivated about the benefit of plaque control and periodontal prophylaxis.
The participants will be selected from the Outpatient Clinic of the Department of Oral Medicine and Periodontology, Faculty of Dentistry, Mansoura University. The patients will be informed about the treatment that they will receive and steps that will be taken. This includes the possible effects or risks and other treatment options according to the rules of the ethical committee of the Faculty of Dentistry, Mansoura University. The subjects must understand this explanation in broad terms. They must be legally competent to give written consent before performing any required steps. The research protocol will be presented to the ethical committee at the Faculty of Dentistry, Mansoura University, to get its approval.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group I treated with C. asiatica nanoemulsion as an adjunct to SRP | Experimental | Drug: Centella asiatica nanoemulsion gel, Procedure: Scaling and Root Planing (SRP)Group I (study group): 15 Patients with periodontitis Stage III will be treated with C. asiatica nanoemulsion as an adjunct to SRP. |
| Group II (positive control group) treated with SRP | Active comparator | Procedure: Scaling and Root Planing (SRP)Group II (positive control): 15 patients with periodontitis Stage III will be treated with scaling and root planing (SRP) alone, with no adjunctive gel application. |
| Group III (negative control group): no intervention | No intervention | –Group III (negative control/healthy control): 15 periodontally healthy participants who will receive no active periodontal intervention; assessed at baseline only |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 25-55 years, either sex
- Diagnosis of periodontal health OR Stage III periodontitis (per 2017 World Workshop Classification)
Key exclusion criteria (12 listed)
- Known allergy or sensitivity to any component of the study medication
- Systemic antibiotics or anti-inflammatory medications within the preceding 6 months
- Uncontrolled diabetes mellitus
- Cardiovascular disease
- Rheumatoid arthritis
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 |
|---|---|---|
| Centella asiatica nanoemulsion gelFollowing scaling and root planing, patients in Group 1 received local subgingival application of Centella asiatica nanoemulsion gel via disposable syringe with a blunt-ended cannula, applied once weekly for 3 months. | Drug | group I treated with C. asiatica nanoemulsion as an adjunct to SRP |
| Scaling and Root Planing (SRP)Full-mouth scaling and root planing using ultrasonic instrumentation and Gracey curettes, plus standardized oral hygiene instructions. | Procedure or surgery | Group II (positive control group) treated with SRP, group I treated with C. asiatica nanoemulsion as an adjunct to SRP |
Primary outcome
Plaque Index
Time frame: Baseline and 3 months (Groups 1 and 2); baseline only (Group 3)
Full-mouth plaque accumulation scored at the mesial, distal, buccal, and lingual/palatal surfaces of each examined tooth on a 0-3 scale, with higher scores indicating greater plaque accumulation. The participant-level score is the average of all recorded surface scores.
Gingival Index
Time frame: Baseline and 3 months (Groups 1 and 2); baseline only (Group 3)
Gingival inflammation was scored at each examined surface on a 0-3 scale based on gingival color, consistency, and presence/absence of bleeding on probing, with higher scores indicating more severe inflammation (0 = clinically healthy gingiva, 3 = severe inflammation with marked redness, edema, ulceration, or spontaneous bleeding).
Gingival Bleeding Index
Time frame: Baseline and 3 months (Groups 1 and 2); baseline only (Group 3)
Presence or absence of bleeding recorded following gentle probing of the gingival margin at each examined site, calculated as the number of bleeding sites divided by the total number of examined sites and expressed as a percentage. Higher percentages indicate greater gingival bleeding.
Periodontal Probing Depth (PPD)
Time frame: Baseline and 3 months (Groups 1 and 2); baseline only (Group 3)
Distance in millimeters from the free gingival margin to the base of the periodontal pocket, measured at multiple sites per tooth using a calibrated periodontal probe. Higher values indicate deeper pockets and greater periodontal destruction.
Clinical Attachment Level (CAL)
Time frame: Baseline and 3 months (Groups 1 and 2); baseline only (Group 3)
Distance in millimeters from the cemento-enamel junction to the base of the periodontal pocket, measured at multiple sites per tooth using a calibrated periodontal probe. Higher values indicate greater loss of periodontal attachment
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 13 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Majed M Alshammari, bachelor principal investigator
faculty of dentistry Mansoura university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Centella asiatica nanoemulsion gel and Scaling and Root Planing (SRP) in people with Periodontal Diseases and Periodontal Bone Loss, run by Mansoura 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 12 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 13 Jul 2026. 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?
Plaque Index (time frame: Baseline and 3 months (Groups 1 and 2); baseline only (Group 3)). The study lists 5 primary outcomes in all. 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 13 Jul 2026.