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

NCT06947603 | Completed

• 1 other identifier: M/70- 14.10.2023
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bleeding; Healing Surgical Wounds

Keywords

Inula Viscosa; Pain; Edema; Trismus; Lower Third Molars

Outcome Measures

Primary Outcomes (2)

• 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

  postprocedural, up to 12 hours

• 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 1: one week after surgery

Study Arms (2)

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

ACTIVE COMPARATOR

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

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

ACTIVE COMPARATOR

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

inula viscosa extract PROCEDURE

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

inula viscosa extract was used for one side of patients after surgical lower third molar removal; nothing was used for other side of patients after surgical lower third molar removal

no inula viscosa extract PROCEDURE

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

inula viscosa extract was used for one side of patients after surgical lower third molar removal; nothing was used for other side of patients after surgical lower third molar removal

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: female participate has to be not pregnant or lactating
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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, ,

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Wataniya University: lead

Study Sites (1)

Al Wataniya Private University

Hama, Hama Government, 00000, Syria

Location

MeSH Terms

Conditions

Hemorrhage; Pain; Edema; Trismus

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Spasm; Neuromuscular Manifestations; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior lecturer

Study Record Dates

• First Submitted: April 3, 2025
• First Posted: April 27, 2025
• Study Start: November 20, 2023
• Primary Completion: March 1, 2025
• Study Completion: March 29, 2025
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)