NCT07364253

Brief Summary

The goal of this study is to examine the effects of propolis gargle on wound healing following third molar surgery and to compare it with chlorhexidine gluconate. The main question it aims to answer is: Is propolis-containing gargle safe and effective alternative to chlorhexidine gluconate following impacted third molar surgery? Does propolis demonstrate comparable outcomes in pain control and mouth opening ?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2022

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

January 16, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
Last Updated

February 2, 2026

Status Verified

January 1, 2026

Enrollment Period

5 months

First QC Date

January 16, 2026

Last Update Submit

January 29, 2026

Conditions

Keywords

third molar surgerypropolis garglechlorhexidine gluconate

Outcome Measures

Primary Outcomes (2)

  • Edema

    Edema (assessed by measuring the distances between the tragus and lip corner, as well as the outer corner of the eye and mandibular corner, with measurements taken twice using a paper ruler and averaged), It was measured before surgery, after surgery second and seventh days.

    Before surgery to after surgery seventh day

  • Pain after surgery

    Patient records were collected on the second and seventh days post-operation. The evaluated parameters included pain (measured using the VAS scale). Visual analog scale is used to measure pain intensity. It consists of a straight line usually 10 cm. 0: no pain, 10: worst pain imaginable. The patient marks the point that best represents their pain.

    After surgery, post- op second and seventh day

Secondary Outcomes (2)

  • Maximum mouth opening

    Before surgery to post surgery seventh day

  • Wound aperture

    From surgery to seventh day after surgery

Study Arms (2)

Propolis gargle

ACTIVE COMPARATOR

Patients were randomly allocated into two groups: one group used 0.12% chlorhexidine gluconate gargle, while the other used a 3% propolis-containing gargle. Gargles were applied twice daily for one minute from postoperative day 2 to day 7. Pain was evaluated using the visual analog scale (VAS), while edema, maximum mouth opening, wound healing, and postoperative complications were assessed preoperatively and on postoperative days 2 and 7.

Procedure: Third molar Surgery with propolis gargle

Chlorhexidine Gluconate gargle

ACTIVE COMPARATOR

Patients were randomly allocated into two groups: one group used 0.12% chlorhexidine gluconate gargle, while the other used a 3% propolis-containing gargle. Gargles were applied twice daily for one minute from postoperative day 2 to day 7. Pain was evaluated using the visual analog scale (VAS), while edema, maximum mouth opening, wound healing, and postoperative complications were assessed preoperatively and on postoperative days 2 and 7.

Procedure: Third molar surgery with chlorhexidine gluconate

Interventions

The patients were anesthetized with inferior alveolar, lingual, and buccal nerve blocks using 4 ml of articaine with 1:100,000 epinephrine (Ultracaine D-S Fort, Aventis). The tooth could be observed by elevating a full-thickness triangular mucoperiosteal flap. The tooth was extracted following an osteotomy using a bur. The tooth was sectioned and extracted, if required. Curettage was conducted in the presence of a residual dental follicle. The wound was sutured with silk thread. All procedures were conducted by the same physician. Postoperatively, antibiotics (amoxicillin combined with clavulanic acid, 2 g daily for 5 days) and analgesics (paracetamol 1 g, up to 4 times daily for 3 days) were recommended. The group was administered a 3% propolis gargle (formulated in an ethanol solution, twice daily for 1 minute, prepared in the Departments of Pharmacology.

Propolis gargle

The patients were anesthetized with inferior alveolar, lingual, and buccal nerve blocks using 4 ml of articaine with 1:100,000 epinephrine (Ultracaine D-S Fort, Aventis). The tooth could be observed by elevating a full-thickness triangular mucoperiosteal flap. The tooth was extracted following an osteotomy using a bur. The tooth was sectioned and extracted, if required. Curettage was conducted in the presence of a residual dental follicle. The wound was sutured with silk thread. All procedures were conducted by the same physician. Postoperatively, antibiotics (amoxicillin combined with clavulanic acid, 2 g daily for 5 days) and analgesics (paracetamol 1 g, up to 4 times daily for 3 days) were recommended. The group was administered chlorhexidine gluconate (0.12%) gargle, twice daily for 1 minute.

Chlorhexidine Gluconate gargle

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of the impacted teeth were classified as Class II level B mesioangular position
  • Patients from a socioeconomic level who can actively use postoperative gargles

You may not qualify if:

  • Individuals with third molars exhibiting acute infection
  • smokers
  • pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University Faculty of Dentistry

Erzurum, Yakutiye, 25240, Turkey (Türkiye)

Location

MeSH Terms

Interventions

chlorhexidine gluconate

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 16, 2026

First Posted

January 23, 2026

Study Start

January 5, 2021

Primary Completion

June 3, 2021

Study Completion

January 7, 2022

Last Updated

February 2, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations