BleedingNCT06947603
Effect of Inula Viscosa Extract on Postoperative Bleeding and Healing After Lower Third Molar Surgery
A study testing inula viscosa extract and no inula viscosa extract in people with Bleeding and Healing Surgical Wounds, run by Al-Wataniya University at 1 site in Syria.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Bleeding, Healing Surgical Wounds
- What is being tested?
- inula viscosa extract and no inula viscosa extract
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSyria
- Study dates
- 20 Nov 2023to 29 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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, ,
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Bleeding, Healing Surgical Wounds
- Being tested
- inula viscosa extract, no inula viscosa extract
- Keywords
- Inula Viscosa, Pain, Edema, Trismus, Lower Third Molars
- Medical subject headings
- Hemorrhage, Pain, Edema, Trismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inula viscosa extractProcedure or surgery
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 extractProcedure or surgery
the other side of patient was left without the application of inula viscosa extract after lower third molar extraction.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: inula viscosa extract; Procedure: no inula viscosa extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: time 1: one week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start20 Nov 2023
- Primary completion1 Mar 2025
- Study completion29 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Wataniya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarek Khaled Abou Agwa, Al-Wataniya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06947603
- Sponsor's protocol ID
- M/70- 14.10.2023
- Status last verified
- Apr 2025
- First submitted
- 3 Apr 2025
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Inula Viscosa Extract on Postoperative Bleeding and Healing After Lower Third Molar Surgery
- ClinicalTrials.gov ID
- NCT06947603
- Acronym / sponsor ID
- M/70- 14.10.2023
- Conditions
- Bleeding, Healing Surgical Wounds
- Keywords
- Inula Viscosa, Pain, Edema, Trismus, Lower Third Molars
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Al-Wataniya UniversityUniversity, hospital or other
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 29 Mar 2025 (actual)
- First posted
- 27 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| inula viscosa extract was used for one side of patients after surgical lower third molar removal | Active comparator | Procedure: inula viscosa extract, Procedure: no inula viscosa extractThe 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 |
| nothing was used for other side of patients after surgical lower third molar removal | Active comparator | Procedure: inula viscosa extract, Procedure: no inula viscosa extractThe 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 |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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, ,
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inula viscosa extractthe 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 | Procedure or surgery | 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 extractthe other side of patient was left without the application of inula viscosa extract after lower third molar extraction. | Procedure or surgery | 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 |
Primary outcome
questionnaire
Time frame: postprocedural, up to 12 hours
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
healing after surgery as assessed by Alkadi 2018
Time frame: time 1: one week after surgery
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inula viscosa extract and no inula viscosa extract in people with Bleeding and Healing Surgical Wounds, run by Al-Wataniya University at 1 site in Syria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
questionnaire (time frame: postprocedural, up to 12 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.