Testing whether an herbal product can reduce gum inflammation when used alongside standard periodontal treatment
| ISRCTN | ISRCTN10262904 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10262904 |
| Sponsor | University of Niš - Faculty of Medicine |
| Funder | Ministarstvo Prosvete, Nauke i Tehnološkog Razvoja |
- Submission date
- 23/01/2026
- Registration date
- 20/02/2026
- Last edited
- 20/02/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Control (SRP) group- patients with periodontitis who received SRP treatment - by ultrasonic scaler Woodpecker and curettage with curettage of periodontal pockets for five consecutive days. The experimental group - patients with periodontitis who received local phytotherapy after causal periodontal therapy.
Who can participate?
Adults who are systemically healthy and diagnosed with moderate periodontitis (Stage II, Grade A) may participate. Participants must have at least 24 natural teeth and radiographic evidence of periodontal bone loss. Individuals who smoke, consume alcohol, have systemic diseases (such as diabetes or immune disorders), or are undergoing systemic drug therapies affecting the gums are not eligible.
What does the study involve?
Participants are randomly assigned to one of two groups. One group receives standard SRP therapy only, while the other receives SRP plus a topical application of the polyherbal phytopreparation. Treatment is performed over five consecutive days. Clinical examinations are carried out before treatment and one month later. Gingival cell samples are collected for microscopic analysis.
What are the possible benefits and risks of participating?
Participants may experience improvement in gingival inflammation and periodontal health. No side effects were observed during the study period. However, mild local reactions are possible, as with any topical dental treatment.
Where is the study run from?
The study is conducted at the Clinic of Dentistry, Faculty of Medicine, University of Niš, Serbia.
When is the study starting and how long is it expected to run for?
Each participant is involved in the study for approximately one month, including treatment and follow-up. The exact start date 18/10/2020, and it is expected to run for four years.
Who is funding the study?
This work was supported by the Ministry of Education, Science, and Technological Development of the Republic of Serbia. The funders had no role in the design of the study; the collection, analysis, or interpretation of data; the writing of the manuscript; or the decision to publish the results.
Who is the main contact?
The study is conducted under the supervision of the Clinic of Dentistry, Faculty of Medicine, University of Niš, Serbia. Principal investigator was dr Milica Petrović, Assistant Professor (milica.petrovic@medfak.ni.ac.rs)
Contact information
Principal investigator
Cara Dušana 28/7
Niš
18000
Serbia
 ORCID ID |
0000-0001-6564-5131 |
|---|---|
| Phone | +381 642373966 |
| milica.petrovic@medfak.ni.ac.rs |
Scientific
Blagoja Parovića 16
18000
18000
Serbia
| ORCID ID |
0000-0003-2880-6519 |
|---|---|
| Phone | +381 691045097 |
| bojana.miladinovic@medfak.ni.ac.rs |
Public
Timočka 11
Niš
18000
Serbia
| ORCID ID |
0000-0001-8551-274X |
|---|---|
| Phone | +381 62328036 |
| dusanka.kitic@medfak.ni.ac.rs |
Principal investigator
Železničkih Kolonija 3a
Niš
18000
Serbia
| ORCID ID |
0000-0003-0463-3246 |
|---|---|
| Phone | +381 642373966 |
| kesic.ljiljanaa@gmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Blinded (masking used) |
| Control | Active |
| Assignment | Parallel |
| Purpose | Supportive care, Treatment |
| Participant information sheet | 48895 Participant_Information_Sheet.pdf |
| Scientific title | Efficacy of a topical polyherbal phytopreparation as an adjunct to scaling and root planing therapy in patients with periodontitis: a randomized controlled clinical study |
| Study acronym | PHYTO-PERIO Trial |
| Study objectives | The primary objective of this randomized controlled clinical study was to evaluate the clinical efficacy of a topical polyherbal phytopreparation (Tinctura paradentoica®, https://www.mocbilja.rs/proizvod/kapi-za-jacanje-desni/) as an adjunct to scaling and root planing (SRP) in patients with stage II, grade A periodontitis, by assessing changes in gingival inflammation (gingival index) and periodontal pocket depth. Secondary objectives included evaluation of cytomorphometric changes in gingival epithelial cells following treatment and exploration of potential mechanistic support using HPLC-guided in silico molecular docking (COX-1/COX-2) and ADME/Tox profiling. |
| Ethics approval(s) |
Approved 23/07/2020, Ethics Committee of Faculty of medicine, University of Niš (Dr Zoran Djindjić Ave 81, Niš, 18000, Serbia; +381 184226644; pravna.sluzba@medfak.ni.ac.rs), ref: 12-6422-2/7 |
| Health condition(s) or problem(s) studied | The efficacy of a polyherbal phytopreparation as an adjunctive therapy to scaling and root planing in patients with periodontitis. |
| Intervention | This study is designed as a randomized controlled clinical trial including 80 adults diagnosed with stage II, grade A periodontitis. After baseline assessment, participants are randomly allocated in a 1:1 ratio into two groups using computer-generated randomization with equal block sizes. Allocation concealment is ensured by sequentially numbered, opaque, sealed envelopes prepared by an independent examiner not involved in enrollment or outcome assessment. Participants and the recruiting investigator remain blinded to group assignment. Control group(SRP): Participants receive causal periodontal therapy consisting of ultrasonic scaling, root planing, polishing and curettage of periodontal pockets performed over five consecutive days (SRP using an ultrasonic scaler and Gracey curettes). Standardized oral hygiene instructions are provided. Experimental group (SRP + phytotherapy): Participants receive the same SRP protocol and oral hygiene instructions as the control arm, followed by topical subgingival application of the polyherbal phytopreparation Tinctura paradentoica®. The intervention is administered locally using a sterile syringe with a 23-gauge needle (110° angulation). A dose of 0.1 mL per periodontal pocket is applied subgingivally under cotton roll isolation for 2 minutes per quadrant, according to the study protocol. Clinical outcomes (gingival index and periodontal pocket depth) are assessed at baseline and at one month after therapy initiation by a single calibrated examiner blinded to treatment allocation. Cytomorphometric analysis of gingival epithelial cells is performed using exfoliative cytology samples collected at baseline and at one month. In addition, the study includes an exploratory HPLC-guided in silico analysis (molecular docking to COX-1/COX-2 and ADME/Tox profiling of identified phenolic constituents) to support mechanistic plausibility. |
| Intervention type | Supplement |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 18/10/2024 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 150 |
| Total final enrolment | 98 |
| Key inclusion criteria | 1. Adults aged 18 to 65 years. 2. Individuals diagnosed with periodontitis based on medical history and clinical evaluation. 3. Presence of at least 24 natural teeth. 4. Radiographic evidence of bone loss. 5. Periodontal status determined using the 2018 classification of periodontal diseases and conditions. 6. Diagnosis of periodontitis confirmed by either interdental clinical attachment loss at two or more non‑adjacent teeth, or buccal/oral clinical attachment loss of 3 mm or more together with periodontal pocket depth of 3 mm or more at two or more teeth. 7. Individuals not meeting the above diagnostic criteria were considered periodontally healthy and therefore not included. |
| Key exclusion criteria | 1. A history of alcohol consumption 2. Tobacco use in any form (past or present) 3. A medical history of anemia 4. Diabetes 5. Hepatitis 6. Tuberculosis 7. AIDS 8. Leukemia 9. Other systemic or hormonal disorders linked to gingival manifestations 10. Those who were undergoing or had previously undergone treatment with systemic hormonal therapy, contraceptive usage, corticosteroids, immunosuppressants, radiation therapy, or chemotherapy before the study started |
| Date of first enrolment | 18/10/2020 |
| Date of final enrolment | 18/08/2024 |
Locations
Countries of recruitment
- Serbia
Study participating centres
Niš
18000
Serbia
Niš
18000
Serbia
Niš
18000
Serbia
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other files | Participant flow diagram | 26/01/2026 | No | No | |
| Other files | Informed Consent Form | 28/01/2026 | No | No | |
| Other files | Schedule of Enrolment, Interventions, and Assessments | 28/01/2026 | No | No | |
| Participant information sheet | 28/01/2026 | No | Yes | ||
| Protocol file | 28/01/2026 | No | No | ||
| Statistical Analysis Plan | 28/01/2026 | No | No |
Additional files
- 48895 Particpant flow diagram.pdf
- Participant flow diagram
- 48895 Participant_Information_Sheet.pdf
- Participant information sheet
- 48895 Schedule of Enrolment, Interventions, and Assessments SPIRIT_Schedule_Addendum.pdf
- Schedule of Enrolment, Interventions, and Assessments
- 48895 Informed_Consent_Form.pdf
- Informed Consent Form
- 48895 Clinical Study Protocol.pdf
- Protocol file
- 48895 Statistical Analysis Plan (SAP).pdf
- Statistical Analysis Plan
Editorial Notes
26/01/2026: Trial's existence confirmed by Ethics Committee of Faculty of medicine, University of Niš.
