Plaque Induced GingivitisPhase 1NCT06888453
Propolis Lozenges Extract and Their Effect on Salivary Biomarkers and on Oral Health Condition in (19_24) Years Old
A Phase 1 study testing lozenges containing propolis in people with Plaque Induced Gingivitis and Mouth Diseases, run by Al-Mustansiriyah University at 1 site in Iraq.
Trial summary
The goal of this clinical trial is to test the efficiency of using lozenges containing propolis extract over one week to control gingival inflammation and plaque accumulation by measuring the clinical periodontal parameters (Gingival index, plaque index) in comparison with a control group given oral hygiene… Read more about this study
- Who is it for?
- Ages 19 to 24 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Plaque Induced Gingivitis, Mouth Diseases, Periodontal Diseases
- What is being tested?
- lozenges containing propolis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIraq
- Study dates
- 23 Mar 2025to 20 Apr 2025
- Phase
- Phase 1
- 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 19 to 24 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age of patients (19_24) who volunteered to participate.
- Apparently, good general health. With no systemic diseases.
- plaque and gingival indices were ranged from (1.1_2.0)
Who cannot join
- 1. Individuals with chronic illnesses, immunocompromised individuals, pregnant women, those on contraceptive medications, and breastfeeding mothers.
- 2. People who use mouthwash at the moment or any preventive modalities. 3. Those taking anti-inflammatory drugs and antibiotics both during the study and in the final four weeks prior.
- 4. Individuals have a history of hypersensitivity to any substance utilized in the current investigation.
- 5. Individuals who have undergone a recent tooth extraction. 6. Individuals with Periodontal pocket depth Equal or less than 4 or attachment loss.
- 7. Individuals who smoke. 8. Individuals with orthodontic equipment, removable dentures, implants.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation the Effects of Propolis Lozenges Extract on Salivary Biomarkers and Its Effect on Oral Health Condition in (19_24) Years Old
The goal of this clinical trial is to test the efficiency of using lozenges containing propolis extract over one week to control gingival inflammation and plaque accumulation by measuring the clinical periodontal parameters (Gingival index, plaque index) in comparison with a control group given oral hygiene instruction only in patients with biofilm induced gingivitis (moderate gingivitis)
Objectives:
- Evaluate the clinical efficiency of using lozenges containing propolis extract over 7 days to control gingival inflammation and plaque accumulation by measuring the clinical periodontal parameters (Gingival index, plaque index) in comparison with a control group given oral hygiene instruction only in patients with biofilm induced gingivitis (moderate gingivitis).
- Measuring levels of salivary cytokines, IL-1Beta, and IL-10 by ELISA at Baseline visit before using lozenges containing propolis and after 7 days of using lozenges containing propolis compared to a control group with oral hygiene instruction only.
- Investigate and compare the association of salivary interleukins of IL-Beta and IL-10 in periodontal health and generalized gingivitis.
- Evaluate the correlation between clinical periodontal parameters and salivary (IL-1Beta and IL-10).
- Evaluate subjects' perception of lozenges containing propolis extract and oral hygiene instructions after 7 days.
Read the detailed description
100 subjects will be enrolled, who show generalized gingivitis (moderate gingivitis) with no Periodontal pocket depth>3 mm, intact periodontium, and no loss of periodontal attachment), caused by the accumulation of plaque. 50 subjects are case that given a lozenge containing propolis and oral hygiene instructions, and 50 subjects were control that were given oral hygiene instructions only. The participants will be asked to chew a lozenge twice per day and Discontinuation of the lozenges will be advised in cases of any allergic reaction. in baseline visit at the beginning, Saliva collection for IL-1β and IL-10 measurement, then clinical periodontal parameters examination starting with gingival index (Loe and Silness in 1963) designed to assess the severity and quality of gingival inflammation in an individual or population. The gingival inflammation is assessed on the basis of color, consistency, and bleeding on probing. A periodontal probe will be run along the gingival margin. The gingiva surrounding the tooth is assessed at four sites: mesio-facial papilla, facial marginal gingiva, disto-facial papilla and lingual marginal gingiva. Then finally followed by the Plaque Index (Loe and Silness in 1963). the data had been recorded from labial/buccal and lingual/palatal surfaces.
First visit after 7 days, from the baseline visit. Saliva collection and clinical periodontal parameters scoring (GI, PI) will be performed again as described at the baseline visit.
- Being tested
- lozenges containing propolis
- Keywords
- gingivitis, plaque, propolis, lozenges
- Medical subject headings
- Mouth Diseases, Periodontal Diseases, Gingivitis, Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lozenges containing propolisDrug
Also called bee glue
lozenges containing propolis Participants will be given the test interventions, lozenges containing propolis, and will be asked to chew twice per day and will be instructed to ordinary oral hygiene instruction, No modifications to the participants' tooth brushing technique will be permitted. Next, the participants will be re-evaluated after 7 days
| Study group | Role | What they receive |
|---|---|---|
| lozenges containing propolis | Experimental | lozenges containing propolis Participants will be given the test interventions, lozenges containing propolis, and will be asked to chew twice per day and will be instructed to ordinary oral hygiene instruction, No modifications to the participants' tooth brushing technique will be permitted. Next, the participants will be re-evaluated after 7 days. Receives: Drug: lozenges containing propolis |
| standard of care | No intervention | Participants will be instructed to ordinary oral hygiene instruction only, No modifications to the participants' tooth brushing technique will be permitted. Next, the participants will be re-evaluated after 7 days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the clinical periodontal parameter (Gingival index)
Subjects will undergo the measurement of the gingival index according to (Loe \& Silness in 1963), designed to assess the severity and quality of gingival inflammation in an individual or population. The gingival inflammation is assessed on the basis of color, consistency, and bleeding on probing. The Gingival Index (GI) scores each site on a 0 to 3 scale
Score 0 : Normal gingiva
score 1: Mild Inflammation- slight change in color, Slight oedema. No bleeding on probing.
score 2: Moderate inflammation-redness, oedema and glazing. Bleeding on probing.
score 3: Sever inflammation-marked redness and edema. Ulceration. Tendency to spontaneous bleeding.
Measured: (0, 7days)
Secondary outcomes (2)
Changes in the clinical periodontal parameter (Plaque index )
To determine the patients' plaque index, their dental plaque thickness was evaluated by probing the mesial, distal, buccal, and palatal surfaces of all teeth using a Williams periodontal probe. The individual's plaque index was determined by summing the values obtained for each tooth and calculating the averages.Silness \& Löe (Silness \& Löe,1964) reference values were taken as a basis The Plaque Index (PI) scores each site on a 0 to 3 scale
Score 0 : No plaque is in the area adjacent to the gingiva.
Score 1: There is a plaque in the form of a thin film on the gingival margin.
Score 2: There is a visible plaque in the gingival pocket and gingival margin.
Score 3: There is a dense plaque in the gingival pocket and on the gingival margin.
Measured: (0, 7days)
Changes in salivary cytokines (IL- 1β , IL-10)
ELISA kit will analyze salivary interleukins, and concentrations are measured according to manufacturing instructions, were picogram per liter for interleukin 1 beta levels and nanogram per milliliter for interleukin 10 levels
0 day: Saliva collection for IL-1β and IL-10 measurement, then clinical periodontal parameters examination starting with the gingival index finally followed by the Plaque index
7 days: Saliva collection and clinical periodontal parameters scoring (GI, PI) will be performed again as described at the baseline visit,
Measured: (0, 7days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start23 Mar 2025
- Primary completion1 Apr 2025
- Study completion20 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Plaque Induced GingivitisStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 100 subjects with plaque induced gingivitis, caused by accumulation of plaque, will be selected and enrolled in this study. Subsequently, subjects will be equally divided case and control groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Mustansiriyah University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Salah Abdulmahdi Finajn, Al-Mustansiriyah University
- Investigators
- ahmed s aljanaby, B.D.S, Principal investigator, Al-Mustansiriyah Universitymohammed K Mahmoud, M.S.C, Study director, Al-Mustansiriyah University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06888453
- Sponsor's protocol ID
- AL-Mustansiriyah University
- Status last verified
- Sep 2025
- First submitted
- 5 Mar 2025
- Last updated
- 24 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shi H, Yang H, Zhang X, Yu LL. Identification and quantification of phytochemical composition and anti-inflammatory and radical scavenging properties of methanolic extracts of Chinese propolis. J Agric Food Chem. 2012 Dec 19;60(50):12403-10. doi: 10.1021/jf3042775. Epub 2012 Dec 5.
PubMed 23176258El-Allaky HS, Wahba NA, Talaat DM, Zakaria AS. Antimicrobial Effect of Propolis Administered through Two Different Vehicles in High Caries Risk Children: A Randomized Clinical Trial. J Clin Pediatr Dent. 2020 Sep 1;44(5):289-295. doi: 10.17796/1053-4625-44.5.1.
PubMed 33181849Alghutaimel H, Matoug-Elwerfelli M, Alhaji M, Albawardi F, Nagendrababu V, Dummer PMH. Propolis Use in Dentistry: A Narrative Review of Its Preventive and Therapeutic Applications. Int Dent J. 2024 Jun;74(3):365-386. doi: 10.1016/j.identj.2024.01.018. Epub 2024 Feb 19.
PubMed 38378400
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation the Effects of Propolis Lozenges Extract on Salivary Biomarkers and Its Effect on Oral Health Condition in (19_24) Years Old
- ClinicalTrials.gov ID
- NCT06888453
- Acronym / sponsor ID
- AL-Mustansiriyah University
- Keywords
- gingivitis, plaque, propolis, lozenges
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Al-Mustansiriyah UniversityUniversity, hospital or other
- Study start
- 23 Mar 2025 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 20 Apr 2025 (actual)
- First posted
- 21 Mar 2025 (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 goal of this clinical trial is to test the efficiency of using lozenges containing propolis extract over one week to control gingival inflammation and plaque accumulation by measuring the clinical periodontal parameters (Gingival index, plaque index) in comparison with a control group given oral hygiene instruction only in patients with biofilm induced gingivitis (moderate gingivitis)
Objectives:
- Evaluate the clinical efficiency of using lozenges containing propolis extract over 7 days to control gingival inflammation and plaque accumulation by measuring the clinical periodontal parameters (Gingival index, plaque index) in comparison with a control group given oral hygiene instruction only in patients with biofilm induced gingivitis (moderate gingivitis).
- Measuring levels of salivary cytokines, IL-1Beta, and IL-10 by ELISA at Baseline visit before using lozenges containing propolis and after 7 days of using lozenges containing propolis compared to a control group with oral hygiene instruction only.
- Investigate and compare the association of salivary interleukins of IL-Beta and IL-10 in periodontal health and generalized gingivitis.
- Evaluate the correlation between clinical periodontal parameters and salivary (IL-1Beta and IL-10).
- Evaluate subjects' perception of lozenges containing propolis extract and oral hygiene instructions after 7 days.
Detailed description
100 subjects will be enrolled, who show generalized gingivitis (moderate gingivitis) with no Periodontal pocket depth>3 mm, intact periodontium, and no loss of periodontal attachment), caused by the accumulation of plaque. 50 subjects are case that given a lozenge containing propolis and oral hygiene instructions, and 50 subjects were control that were given oral hygiene instructions only. The participants will be asked to chew a lozenge twice per day and Discontinuation of the lozenges will be advised in cases of any allergic reaction. in baseline visit at the beginning, Saliva collection for IL-1β and IL-10 measurement, then clinical periodontal parameters examination starting with gingival index (Loe and Silness in 1963) designed to assess the severity and quality of gingival inflammation in an individual or population. The gingival inflammation is assessed on the basis of color, consistency, and bleeding on probing. A periodontal probe will be run along the gingival margin. The gingiva surrounding the tooth is assessed at four sites: mesio-facial papilla, facial marginal gingiva, disto-facial papilla and lingual marginal gingiva. Then finally followed by the Plaque Index (Loe and Silness in 1963). the data had been recorded from labial/buccal and lingual/palatal surfaces.
First visit after 7 days, from the baseline visit. Saliva collection and clinical periodontal parameters scoring (GI, PI) will be performed again as described at the baseline visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 100 subjects with plaque induced gingivitis, caused by accumulation of plaque, will be selected and enrolled in this study. Subsequently, subjects will be equally divided case and control groups
| Arm | Type | Receives |
|---|---|---|
| lozenges containing propolis | Experimental | Drug: lozenges containing propolislozenges containing propolis Participants will be given the test interventions, lozenges containing propolis, and will be asked to chew twice per day and will be instructed to ordinary oral hygiene instruction, No modifications to the participants' tooth brushing technique will be permitted. Next, the participants will be re-evaluated after 7 days. |
| standard of care | No intervention | –Participants will be instructed to ordinary oral hygiene instruction only, No modifications to the participants' tooth brushing technique will be permitted. Next, the participants will be re-evaluated after 7 days. |
Who may qualify
- Ages
- 19 to 24 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age of patients (19_24) who volunteered to participate.
- Apparently, good general health. With no systemic diseases.
- plaque and gingival indices were ranged from (1.1_2.0)
Key exclusion criteria (5 listed)
- 1. Individuals with chronic illnesses, immunocompromised individuals, pregnant women, those on contraceptive medications, and breastfeeding mothers.
- 2. People who use mouthwash at the moment or any preventive modalities. 3. Those taking anti-inflammatory drugs and antibiotics both during the study and in the final four weeks prior.
- 4. Individuals have a history of hypersensitivity to any substance utilized in the current investigation.
- 5. Individuals who have undergone a recent tooth extraction. 6. Individuals with Periodontal pocket depth Equal or less than 4 or attachment loss.
- 7. Individuals who smoke. 8. Individuals with orthodontic equipment, removable dentures, implants.
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 |
|---|---|---|
| lozenges containing propolisAlso: bee gluelozenges containing propolis Participants will be given the test interventions, lozenges containing propolis, and will be asked to chew twice per day and will be instructed to ordinary oral hygiene instruction, No modifications to the participants' tooth brushing technique will be permitted. Next, the participants will be re-evaluated after 7 days | Drug | lozenges containing propolis |
Primary outcome
Changes in the clinical periodontal parameter (Gingival index)
Time frame: (0, 7days)
Subjects will undergo the measurement of the gingival index according to (Loe \& Silness in 1963), designed to assess the severity and quality of gingival inflammation in an individual or population. The gingival inflammation is assessed on the basis of color, consistency, and bleeding on probing. The Gingival Index (GI) scores each site on a 0 to 3 scale Score 0 : Normal gingiva score 1: Mild Inflammation- slight change in color, Slight oedema. No bleeding on probing. score 2: Moderate inflammation-redness, oedema and glazing. Bleeding on probing. score 3: Sever inflammation-marked redness and edema. Ulceration. Tendency to spontaneous bleeding.
2 secondary outcomes
Changes in the clinical periodontal parameter (Plaque index )
Time frame: (0, 7days)
Changes in salivary cytokines (IL- 1β , IL-10)
Time frame: (0, 7days)
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 24 Sep 2025.
- Background: PubMed 23176258Shi H, Yang H, Zhang X, Yu LL. Identification and quantification of phytochemical composition and anti-inflammatory and radical scavenging properties of methanolic extracts of Chinese propolis. J Agric Food Chem. 2012 Dec 19;60(50):12403-10. doi: 10.1021/jf3042775. Epub 2012 Dec 5.
- Background: PubMed 33181849El-Allaky HS, Wahba NA, Talaat DM, Zakaria AS. Antimicrobial Effect of Propolis Administered through Two Different Vehicles in High Caries Risk Children: A Randomized Clinical Trial. J Clin Pediatr Dent. 2020 Sep 1;44(5):289-295. doi: 10.17796/1053-4625-44.5.1.
- Background: PubMed 38378400Alghutaimel H, Matoug-Elwerfelli M, Alhaji M, Albawardi F, Nagendrababu V, Dummer PMH. Propolis Use in Dentistry: A Narrative Review of Its Preventive and Therapeutic Applications. Int Dent J. 2024 Jun;74(3):365-386. doi: 10.1016/j.identj.2024.01.018. Epub 2024 Feb 19.
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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.
ahmed s aljanaby, B.D.S principal investigator
Al-Mustansiriyah University
mohammed K Mahmoud, M.S.C study director
Al-Mustansiriyah University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing lozenges containing propolis in people with Plaque Induced Gingivitis and Mouth Diseases, run by Al-Mustansiriyah University at 1 site in Iraq.
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 3 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 24 Sep 2025. 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 Iraq. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Changes in the clinical periodontal parameter (Gingival index) (time frame: (0, 7days)). 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 NCT06888453, which also lists 3 linked publications.
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 24 Sep 2025.