ClinicalTrials.gg
CompletedNCT07907484Updated Oct 30, 2026

Effectiveness of Propolis on Changes in Salivary α-Amylase Levels Following Mandibular Third Molar Odontectomy: A Randomized Controlled Trial

An interventional study of Propolis gel (10%) in Impacted Mandibular Third Molar, sponsored by I Gede Surya Septadinata. Completed at 1 site in Indonesia. Open to participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-10-30.

Sponsored by I Gede Surya Septadinata · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 9 months after the study started (first participant enrolled Jan 2025, registered Oct 2026).
Updated Oct 30, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
All
01

Study 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.

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.

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.

02

Conditions studied

  • Impacted Mandibular Third Molar

Keywords

  • Propolis
  • Salivary Alpha-Amylase
  • Mandibular Third Molar
  • Odontectomy
03

In context

Lead sponsor

This is the only study on the registry with I Gede Surya Septadinata as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients who provided written .
  • 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).

Exclusion criteria

Exclusion Criteria:

  • 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
26 participants (actual)

Study arms

  • Experimental
    Propolis Group

    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.

    Drug: Propolis gel (10%)

  • No intervention
    Control Group

    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.

Interventions

  • Propolis gel was administered as the experimental treatment in participants undergoing mandibular third molar odontectomy.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Postoperative days 1, 3, and 7

07

Study locations

1 site
  • Rumah Sakit Gigi dan Mulut Pendidikan Universitas Hasanuddin
    Makassar, South Sulawesi, Indonesia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 30, 2026
Show all 1 update
  1. Oct 30, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07907484
Lead sponsor
I Gede Surya Septadinata
Responsible party
I Gede Surya Septadinata (Principal Investigator, Hasanuddin University) — Sponsor-investigator
First posted
Oct 30, 2026
Start date
Jan 1, 2025
Primary completion
Jul 16, 2025
Completion
Jul 16, 2025
Last update
Oct 30, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Propolis

Start the discussion