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CompletedNCT06947603Updated Apr 27, 2025

Effect of Inula Viscosa Extract on Postoperative Bleeding and Healing After Lower Third Molar Surgery

An interventional study of inula viscosa extract and no inula viscosa extract in Bleeding and Healing Surgical Wounds, sponsored by Al-Wataniya University. Completed at 1 site in Syrian Arab Republic. Open to participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2025-04-27.

Sponsored by Al-Wataniya University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled Nov 2023, registered Apr 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
01

Study summary

In oral surgery, the operation of the impacted third molar is one of the most common surgical procedures performed by oral and maxillofacial surgeons .Several attempts have been made to reduce the postoperative outcome of the removal of the third molar post-surgery.The bioactive components in Inula extracts consist of sesquiterpene lactones, and the major components are alantolactone and isoalantolactone .]. Inula has Antioxidant, antihyperglycemic, antimicrobial, antibacterial, antifungal, anticancer and anti-inflammatory effects. the purpose of this study was to assess the effects of inula viscosa on the postoperative period of the third molar surgery by evaluating bleeding, and healing.

Read the detailed description

material and method: A total of 30 patients aged 18 to 35 years were enrolled in the study. The inclusion criteria for the study group were as follows: bilateral lower impacted third molars (those that can only be surgically extracted through bone osteotomy with or without the need for tooth sectioning) , non-smokers, good general health with no systemic diseases, not pregnant or lactating, no medication taken that could influence wound healing after surgery, and no oral inflammation, such as periodontal disease. The study sample was divided into two equal groups based on the type of pharmaceutical substance applied within the alveolar socket after the extraction of impacted molars. In the first group (Inula group), an extract of INULA was used, while in the second group (controlled group), nothing was used. In both groups, the pharmaceutical substance was applied to one side after the extraction of the impacted molar in each patient, while the other side was left without the application of any pharmaceutical substance after extraction. It is noteworthy that the second extraction on the patient was only performed after complete healing of the controlled side. Before the surgical procedure, each patient received information about the surgery, postoperative recommendations, and possible complications. They signed a consent form indicating their agreement to participate in the study. The study protocol and consent form were approved by Al-Wataniya Private University, Syria. after syrgery All patients received postoperative instructions.

Measurement of bleeding:

A subjective method was used to compare post-operative bleeding between the two techniques in this clinical trial. The patient was asked to count the number of gauze pads for the patient to bite on gauzes used to stop bleeding, for each surgical site, on each day post-operatively, also, the patient reported the time needed to achieve a bleeding-free surgical site measurement of post-operative healing:

The assessment of socket healing was carried out at one week after surgery using a five-grade index to measure the degree of socket epithelization, which was designed by (Alkadi 2018) as follows :

Healing grade

  • Very poor (1) : Clinical criteria Tissue color: ˃ 50% of gingivae red , Response to palpation: bleeding, Granulation tissue: present, Incision margin: not epithelialized, with loss of epithelium , beyond margins .Suppuration: present
  • Poor (2) : Tissue color:˃ 50% of gingivae red, Response to palpation: bleeding, Granulation tissue: present Incision margin: not epithelialized, with connective tissue exposed, Suppuration: none
  • Good (3) : Tissue color: ˂ 50% of gingivae red, Response to palpation: no bleeding, Granulation tissue: none, Incision margin: no connective tissue exposed, Suppuration: none
  • Very good (4) :Tissue color: ˂ 25% of gingivae red, Response to palpation: no bleeding, Granulation tissue: none, Incision margin: no connective tissue exposed, Suppuration: none
  • Excellent (5) :Tissue color: all gingivae pink, Response to palpation: no bleeding, Granulation tissue: none, Incision margin: no connective tissue exposed, Suppuration: none Statistical analysis Recorded data were analyzed using the IBM SPSS 20.0 software (Statistical Package for the Social Science, SPSS Inc., Chicago, IL, USA).
02

Conditions studied

  • Bleeding
  • Healing Surgical Wounds

Keywords

  • Inula Viscosa
  • Pain
  • Edema
  • Trismus
  • Lower Third Molars
03

In context

Hemorrhage

3,000 studies on the registry are indexed under Hemorrhage; 474 are open to participants now.

This study's enrollment of 30 is below the median of 100 across 1,985 interventional studies indexed under Hemorrhage.

Browse Hemorrhage studies →

Lead sponsor

Al-Wataniya University is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patients have bilateral lower impacted third molars (those that can only be surgically extracted through bone osteotomy with or without the need for tooth sectioning)
  • good general health with no systemic diseases, ,

Exclusion criteria

Exclusion Criteria:

  • non-smokers,
  • no medication taken that could influence wound healing after surgery,
  • and no oral inflammation, such as periodontal disease,
  • for woman not pregnant or lactating.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
30 participants (actual)

Study arms

  • Active comparator
    inula viscosa extract was used for one side of patients after surgical lower third molar removal

    The study sample was divided into two equal groups based on the type of pharmaceutical substance applied within the alveolar socket after the extraction of impacted molars. In the first group (Inula group), an extract of INULA was used

    Procedure: inula viscosa extract · Procedure: no inula viscosa extract

  • Active comparator
    nothing was used for other side of patients after surgical lower third molar removal

    The study sample was divided into two equal groups based on the type of pharmaceutical substance applied within the alveolar socket after the extraction of impacted molars. In the second group (control group), nothing was used

    Procedure: inula viscosa extract · Procedure: no inula viscosa extract

Interventions

  • Procedureinula viscosa extract

    the topical gel of inula viscosa was applied to one side after the extraction of the impacted molar in each patient, while the other side was left without the application of any pharmaceutical substance after extraction

  • Procedureno inula viscosa extract

    the other side of patient was left without the application of inula viscosa extract after lower third molar extraction.

06

What researchers measure

Primary outcomes

  1. questionnaire

    Measurement of bleeding: A subjective method was used to compare post-operative bleeding between the two techniques in this clinical trial. The patient was asked to count the number of gauze pads for the patient to bite on gauzes used to stop bleeding, for each surgical site, on each day post-operatively, also, the patient reported the time needed to achieve a bleeding-free surgical site

    Time frame: postprocedural, up to 12 hours

  2. healing after surgery as assessed by Alkadi 2018

    The assessment of socket healing was carried out at one week after surgery using a five-grade index to measure the degree of socket epithelization, which was designed by (Alkadi 2018) as follows : * Very poor (1) : Clinical criteria Tissue color: ˃ 50% of gingivae red , Response to palpation: bleeding, Granulation tissue: present, Incision margin: not epithelialized, with loss of epithelium , beyond margins .Suppuration: present * Poor (2) : Tissue color:˃ 50% of gingivae red, Response to palpation: bleeding, Granulation tissue: present Incision margin: not epithelialized, with connective tissue exposed, Suppuration: none * Good (3) : Tissue color: ˂ 50% of gingivae red, Response to palpation: no bleeding, Granulation tissue: none, Incision margin: no connective tissue exposed, Suppuration: none * Very good (4) :Tissue color: ˂ 25% of gingivae red, Response to palpation: no bleeding, Granulation

    Time frame: time 1: one week after surgery

07

Study locations

1 site
  • Al Wataniya Private University
    Hama, Hama Government 00000, Syrian Arab Republic
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06947603
Lead sponsor
Al-Wataniya University
Responsible party
Tarek Khaled Abou Agwa (Senior lecturer, Al-Wataniya University) — Principal investigator
First posted
Apr 27, 2025
Start date
Nov 20, 2023
Primary completion
Mar 1, 2025
Completion
Mar 29, 2025
Last update
Apr 27, 2025

Oversight

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

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