Third Molar ExtractionNCT06761664
Decreasing Edema with Platysma Exercises Following Third Molar Extraction Surgery
A study testing Platysma Exercise Group in people with Third Molar Extraction, run by Melek Volkan Yazici at 1 site in Turkey (Türkiye).
Trial summary
This study will investigate the effects of a platysma muscle exercise on edema following third molar extraction surgery. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Third Molar Extraction
- What is being tested?
- Platysma Exercise Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Jul 2024to 4 Nov 2024
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged 18-40,
- Those requiring impacted third molar extraction
- Those with no systemic health conditions, were included in the study
- Those who accepted to participate in the study
Who cannot join
- Those who had systemic diseases
- Those who were taking medications that could interfere with inflammation, or healing,
- Those who were pregnant or breastfeeding,
- Those who had infections or pathologies involving teeth 38 and 48,
- Those who were unable to comply with postoperative recommendations or required therapeutic interventions outside the study protocol
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University, Faculty of Dentistry
Ankara, Cankaya, 06560
About this study
Official title: Decreasing Edema with Platysma Exercises Following Third Molar Extraction Surgery: a Randomized Controlled Trial
This study will investigate the effects of a platysma muscle exercise on edema following third molar extraction surgery.
Read the detailed description
The investigators hypothesized that, during the muscle contraction of the platysma, the vascular structures will be subjected to a pump effect, leading to an increase in venous circulation. Additionally, due to its connection to the fascia, the investigators propose that platysma contractions may mobilize the fascia and stimulate the lymph nodes, thereby improving interstitial fluid flow. This could lead to an effective treatment option for decreasing edema after third molar tooth extraction. Therefore, this study aims to investigate the effects of platysma exercises applied after third molar tooth extraction on edema while observing the differences on pain and trismus.
- Conditions
- Third Molar Extraction
- Being tested
- Platysma Exercise Group, Control (Standard treatment)
- Keywords
- Third molar extraction, Platysma muscle, Exercise, Edema
- Medical subject headings
- Motor Activity, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platysma Exercise GroupOther
The participants in this group will perform a platysma exercise for 7 days following third molar extraction surgery.
Control (Standard treatment)Other
Participants in this group will receive routine treatment following third molar extraction.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants in this group will perform exercises of the platysma muscle after third molar extraction surgery. Receives: Other: Platysma Exercise Group |
| Control (Usual treatment) | Active comparator | Participants in this group will undergo routine treatment after third molar extraction surgery. Receives: Other: Control (Standard treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Facial Edema
Edema will be measured by taking five distinct facial measurements using a standard plastic tape measure (accuracy ±0.5 mm), ensuring the tape makes contact with the skin. The following measurements will be recorded: (a) the distance between the most posterior point of the tragus and the most lateral point of the lip commissure; (b) from the tragus to the chin mid point; (c) from the tragus to the lateral canthus of the eye; (d) from the lateral canthus to the lowest point of the mandibular angle; and (e) from the mandibular angle to the middle of the nasal bone.
Measured: Change of facial edema from baseline to 7 days
Secondary outcomes (2)
Pain following third molar extraction
Pain will be assessed using a 100 mm visual analog scale. Patients will be asked to mark the point on the scale that best represented their level of pain. The scale ranges from 0, indicating no pain, to 10, representing the worst pain imaginable pain.
Measured: Change in pain scores from baseline to 7 days
Trismus
Trismus will be assessed by measuring the maximum inter-incisal distance using callipers to record the widest mouth opening.
Measured: Change of trismus from baseline to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start17 Jul 2024
- Primary completion30 Aug 2024
- Study completion4 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Third Molar ExtractionStudies 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
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melek Volkan Yazici
- Sponsor type
- University, hospital or other
- Collaborators
- Gazi University, Ankara University
- Responsible party
- Sponsor-investigator, Melek Volkan Yazici, Yuksek Ihtisas University
- Investigators
- GOKHAN YAZICI, A/Prof, Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06761664
- Sponsor's protocol ID
- Platysma
- Status last verified
- Jan 2025
- First submitted
- 1 Jan 2025
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to ethical reasons data can not be directly shared. Data can be provided upon request.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decreasing Edema with Platysma Exercises Following Third Molar Extraction Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06761664
- Acronym / sponsor ID
- Platysma
- Conditions
- Third Molar Extraction
- Keywords
- Third molar extraction, Platysma muscle, Exercise, Edema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Melek Volkan YaziciUniversity, hospital or other
- Collaborators
- Gazi University, Ankara University
- Study start
- 17 Jul 2024 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 4 Nov 2024 (actual)
- First posted
- 7 Jan 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.
This study will investigate the effects of a platysma muscle exercise on edema following third molar extraction surgery.
Detailed description
The investigators hypothesized that, during the muscle contraction of the platysma, the vascular structures will be subjected to a pump effect, leading to an increase in venous circulation. Additionally, due to its connection to the fascia, the investigators propose that platysma contractions may mobilize the fascia and stimulate the lymph nodes, thereby improving interstitial fluid flow. This could lead to an effective treatment option for decreasing edema after third molar tooth extraction. Therefore, this study aims to investigate the effects of platysma exercises applied after third molar tooth extraction on edema while observing the differences on pain and trismus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Platysma Exercise GroupParticipants in this group will perform exercises of the platysma muscle after third molar extraction surgery. |
| Control (Usual treatment) | Active comparator | Other: Control (Standard treatment)Participants in this group will undergo routine treatment after third molar extraction surgery. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients aged 18-40,
- Those requiring impacted third molar extraction
- Those with no systemic health conditions, were included in the study
- Those who accepted to participate in the study
Key exclusion criteria (5 listed)
- Those who had systemic diseases
- Those who were taking medications that could interfere with inflammation, or healing,
- Those who were pregnant or breastfeeding,
- Those who had infections or pathologies involving teeth 38 and 48,
- Those who were unable to comply with postoperative recommendations or required therapeutic interventions outside the study protocol
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 |
|---|---|---|
| Platysma Exercise GroupThe participants in this group will perform a platysma exercise for 7 days following third molar extraction surgery. | Other | Intervention |
| Control (Standard treatment)Participants in this group will receive routine treatment following third molar extraction. | Other | Control (Usual treatment) |
Primary outcome
Facial Edema
Time frame: Change of facial edema from baseline to 7 days
Edema will be measured by taking five distinct facial measurements using a standard plastic tape measure (accuracy ±0.5 mm), ensuring the tape makes contact with the skin. The following measurements will be recorded: (a) the distance between the most posterior point of the tragus and the most lateral point of the lip commissure; (b) from the tragus to the chin mid point; (c) from the tragus to the lateral canthus of the eye; (d) from the lateral canthus to the lowest point of the mandibular angle; and (e) from the mandibular angle to the middle of the nasal bone.
2 secondary outcomes
Pain following third molar extraction
Time frame: Change in pain scores from baseline to 7 days
Trismus
Time frame: Change of trismus from baseline to 7 days
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 8 Jan 2025.
- Individual participant dataSharing planned: No. Due to ethical reasons data can not be directly shared. Data can be provided upon request.
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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.
GOKHAN YAZICI, A/Prof principal investigator
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platysma Exercise Group in people with Third Molar Extraction, run by Melek Volkan Yazici at 1 site in Turkey (Türkiye).
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 4 inclusion and 5 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 8 Jan 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 Turkey (Türkiye). 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?
Facial Edema (time frame: Change of facial edema from baseline to 7 days). 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 8 Jan 2025.