Impacted Mandibular Third MolarNCT07907484
Effectiveness of Propolis on Changes in Salivary α-Amylase Levels Following Mandibular Third Molar Odontectomy: A Randomized Controlled Trial
A study testing Propolis gel (10%) in people with Impacted Mandibular Third Molar, run by I Gede Surya Septadinata at 1 site in Indonesia.
Trial summary
This study evaluated whether propolis could influence salivary alpha-amylase levels following surgical removal of impacted mandibular third molars (lower wisdom teeth). Salivary alpha-amylase is an enzyme that can be measured in saliva and may reflect the body's physiological response to surgical stress. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Impacted Mandibular Third Molar
- What is being tested?
- Propolis gel (10%)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jan 2025to 16 Jul 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients who provided written informed consent.
- Male or female patients aged 20-40 years.
- Patients willing to participate in the study and undergo mandibular third molar odontectomy at the Dental and Oral Teaching Hospital of Hasanuddin University during January-July 2025.
- Patients with complete supporting radiographic examinations, including orthopantomography (OPG) or periapical radiographs.
- Patients with good oral hygiene according to the Simplified Oral Hygiene Index (OHI-S).
- Patients scheduled for mandibular third molar odontectomy with low-to-moderate surgical difficulty according to the Indonesian National Guidelines for Medical Services (PNPK).
Who cannot join
- Patients who did not complete the required examinations and follow-up evaluations according to the study protocol.
- Patients presenting with infection or swelling at the mandibular third molar surgical site.
- Patients with a history of systemic disease.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Rumah Sakit Gigi dan Mulut Pendidikan Universitas Hasanuddin
Makassar, South Sulawesi
About this study
This study evaluated whether propolis could influence salivary alpha-amylase levels following surgical removal of impacted mandibular third molars (lower wisdom teeth). Salivary alpha-amylase is an enzyme that can be measured in saliva and may reflect the body's physiological response to surgical stress.
A total of 26 adults aged 20-40 years who underwent mandibular third molar surgery participated in this randomized controlled trial. Participants were allocated to two groups: 13 received propolis treatment and 13 were assigned to a control group.
Read more
Saliva samples were collected on postoperative days 1, 3, and 7 to measure changes in salivary alpha-amylase levels using an enzyme-linked immunosorbent assay (ELISA).
The study aimed to determine whether propolis treatment was associated with different postoperative salivary alpha-amylase patterns compared with the control group. The research was conducted at the Dental and Oral Hospital of Hasanuddin University, Makassar, Indonesia.
Read the detailed description
This single-center, two-arm randomized controlled trial investigated the effect of propolis treatment on postoperative salivary alpha-amylase levels in patients undergoing mandibular third molar odontectomy.
The study included 26 participants aged 20-40 years who required surgical removal of impacted mandibular third molars classified as Pell and Gregory Class II, Position A. Participants were allocated to a propolis group (n = 13) or a control group (n = 13).
The study used a posttest-only design with repeated postoperative measurements. Saliva samples were obtained on postoperative days 1, 3, and 7. Salivary alpha-amylase concentrations were determined using an enzyme-linked immunosorbent assay (ELISA).
The primary objective was to compare postoperative changes in salivary alpha-amylase levels between the propolis and control groups across the three observation periods.
The clinical procedures were conducted at the Oral and Maxillofacial Surgery Clinic of the Dental and Oral Teaching Hospital, Hasanuddin University, Makassar, Indonesia. Biochemical analysis of saliva samples was performed at the HumRC Laboratory, Faculty of Medicine, Hasanuddin University.
The study received ethical approval under reference number 073/KEPK FKG-RSGM UH/EA/XI/2024.
- Conditions
- Impacted Mandibular Third Molar
- Being tested
- Propolis gel (10%)
- Keywords
- Propolis, Salivary Alpha-Amylase, Mandibular Third Molar, Odontectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propolis gel (10%)Drug
Propolis gel was administered as the experimental treatment in participants undergoing mandibular third molar odontectomy.
| Study group | Role | What they receive |
|---|---|---|
| Propolis Group | Experimental | Participants underwent mandibular third molar odontectomy and received propolis gel as the study intervention. Postoperative salivary alpha-amylase levels were assessed on days 1, 3, and 7. Receives: Drug: Propolis gel (10%) |
| Control Group | No intervention | Participants underwent mandibular third molar odontectomy without receiving the experimental propolis treatment. Postoperative salivary alpha-amylase levels were assessed on days 1, 3, and 7. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary Alpha-Amylase Concentration
Salivary alpha-amylase concentration was measured using an enzyme-linked immunosorbent assay (ELISA) in saliva samples collected on postoperative days 1, 3, and 7. Measurements were compared between participants receiving propolis and those in the control group to evaluate differences in postoperative salivary alpha-amylase patterns.
Measured: Postoperative days 1, 3, and 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start1 Jan 2025
- Primary completion16 Jul 2025
- Study completion16 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impacted Mandibular Third MolarStudies 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
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- I Gede Surya Septadinata
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, I Gede Surya Septadinata, Hasanuddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07907484
- Sponsor's protocol ID
- PROPOLIS-AMY1-2024-001
- Status last verified
- Oct 2026
- First submitted
- 24 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- 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 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Propolis on Changes in Salivary α-Amylase Levels Following Mandibular Third Molar Odontectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07907484
- Acronym / sponsor ID
- PROPOLIS-AMY1-2024-001
- Conditions
- Impacted Mandibular Third Molar
- Keywords
- Propolis, Salivary Alpha-Amylase, Mandibular Third Molar, Odontectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- I Gede Surya SeptadinataUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 16 Jul 2025 (actual)
- Study completion
- 16 Jul 2025 (actual)
- First posted
- 30 Oct 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.
This study evaluated whether propolis could influence salivary alpha-amylase levels following surgical removal of impacted mandibular third molars (lower wisdom teeth). Salivary alpha-amylase is an enzyme that can be measured in saliva and may reflect the body's physiological response to surgical stress.
A total of 26 adults aged 20-40 years who underwent mandibular third molar surgery participated in this randomized controlled trial. Participants were allocated to two groups: 13 received propolis treatment and 13 were assigned to a control group.
Saliva samples were collected on postoperative days 1, 3, and 7 to measure changes in salivary alpha-amylase levels using an enzyme-linked immunosorbent assay (ELISA).
The study aimed to determine whether propolis treatment was associated with different postoperative salivary alpha-amylase patterns compared with the control group. The research was conducted at the Dental and Oral Hospital of Hasanuddin University, Makassar, Indonesia.
Detailed description
This single-center, two-arm randomized controlled trial investigated the effect of propolis treatment on postoperative salivary alpha-amylase levels in patients undergoing mandibular third molar odontectomy.
The study included 26 participants aged 20-40 years who required surgical removal of impacted mandibular third molars classified as Pell and Gregory Class II, Position A. Participants were allocated to a propolis group (n = 13) or a control group (n = 13).
The study used a posttest-only design with repeated postoperative measurements. Saliva samples were obtained on postoperative days 1, 3, and 7. Salivary alpha-amylase concentrations were determined using an enzyme-linked immunosorbent assay (ELISA).
The primary objective was to compare postoperative changes in salivary alpha-amylase levels between the propolis and control groups across the three observation periods.
The clinical procedures were conducted at the Oral and Maxillofacial Surgery Clinic of the Dental and Oral Teaching Hospital, Hasanuddin University, Makassar, Indonesia. Biochemical analysis of saliva samples was performed at the HumRC Laboratory, Faculty of Medicine, Hasanuddin University.
The study received ethical approval under reference number 073/KEPK FKG-RSGM UH/EA/XI/2024.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propolis Group | Experimental | Drug: Propolis gel (10%)Participants underwent mandibular third molar odontectomy and received propolis gel as the study intervention. Postoperative salivary alpha-amylase levels were assessed on days 1, 3, and 7. |
| Control Group | No intervention | –Participants underwent mandibular third molar odontectomy without receiving the experimental propolis treatment. Postoperative salivary alpha-amylase levels were assessed on days 1, 3, and 7. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients who provided written informed consent.
- Male or female patients aged 20-40 years.
- Patients willing to participate in the study and undergo mandibular third molar odontectomy at the Dental and Oral Teaching Hospital of Hasanuddin University during January-July 2025.
- Patients with complete supporting radiographic examinations, including orthopantomography (OPG) or periapical radiographs.
- Patients with good oral hygiene according to the Simplified Oral Hygiene Index (OHI-S).
Key exclusion criteria (3 listed)
- Patients who did not complete the required examinations and follow-up evaluations according to the study protocol.
- Patients presenting with infection or swelling at the mandibular third molar surgical site.
- Patients with a history of systemic disease.
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 |
|---|---|---|
| Propolis gel (10%)Propolis gel was administered as the experimental treatment in participants undergoing mandibular third molar odontectomy. | Drug | Propolis Group |
Primary outcome
Salivary Alpha-Amylase Concentration
Time frame: Postoperative days 1, 3, and 7
Salivary alpha-amylase concentration was measured using an enzyme-linked immunosorbent assay (ELISA) in saliva samples collected on postoperative days 1, 3, and 7. Measurements were compared between participants receiving propolis and those in the control group to evaluate differences in postoperative salivary alpha-amylase patterns.
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 30 Oct 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.
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 Propolis gel (10%) in people with Impacted Mandibular Third Molar, run by I Gede Surya Septadinata at 1 site in Indonesia.
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 6 inclusion and 3 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 30 Oct 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 Indonesia. 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?
Salivary Alpha-Amylase Concentration (time frame: Postoperative days 1, 3, and 7). 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 30 Oct 2026.