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

NCT ID: NCT06947603

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-20
• Study Completion Date: 2025-03-29

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.

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).

Conditions

Bleeding; Healing Surgical Wounds

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

inula viscosa extract

Intervention Type: 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

no inula viscosa extract

Intervention Type: PROCEDURE

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

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

Group Type: ACTIVE_COMPARATOR

inula viscosa extract

Intervention Type: 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

no inula viscosa extract

Intervention Type: PROCEDURE

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

Interventions

inula 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

Intervention Type: PROCEDURE

no inula viscosa extract

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Al-Wataniya University

OTHER

Sponsor Role: lead

Responsible Party

Tarek Khaled Abou Agwa

Senior lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Al Wataniya Private University

Hama, Hama Government, Syria

Countries

Syria

Other Identifiers

M/70- 14.10.2023

Identifier Type: -

Identifier Source: org_study_id