Impacted Third Molar Toothwisdom toothNCT06787027
Effect of Manual Massage Technique on Swelling, Pain and Mouth Opening After Bilateral Lower Third Molar Surgery
A study testing Manual Lymphatic Drainage technique and Conventional Treatment group in people with Impacted Third Molar Tooth and Swelling/ Edema, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to evaluate the effect of manual lymphatic drainage on pain, edema and trismus after impacted mandibular third molar surgery. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Impacted Third Molar Tooth, Swelling/ Edema, Pain
- What is being tested?
- Manual Lymphatic Drainage technique and Conventional Treatment group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2018to 1 Sep 2018
- 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
- good general health conditions;
- presence of bilateral and symmetrical impacted third molars (according to the classifications of Winter and Pell and Gregory);
Who cannot join
- no clinical evidence of major facial asymmetry;
- use of medication that would influence or alter wound healing;
- temporomandibular joint disorder history;
- smoking
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir Katip Çelebi University
Izmir, Çiğli, 35575
About this study
Official title: Evaluation of the Effect of Manual Lymphatic Drainage Method on Edema, Pain and Trismus After Impacted Bilateral Mandibular Third Molar Surgery: a Randomized Clinical Trial
The aim of this study was to evaluate the effect of manual lymphatic drainage on pain, edema and trismus after impacted mandibular third molar surgery.
Read the detailed description
This study is a randomized controlled split-mouth trial. A total of 46 healthy patients who presented to our department for the extraction of impacted mandibular third molars were included in this study.The inclusion criteria were as follows: presence of pericoronal infection, no recent use of anti-inflammatory medications, symmetrical impactions on both sides, asymptomatic cases, and class 2, position B or C, vertical and mesioangular impactions. Impactions were classified using the Pell and Gregory classification system.
Exclusion criteria included patients who declined participation, pregnant or lactating individuals, patients with penicillin allergies, those with chronic diseases that could affect healing, uncooperative patients. Following the surgery, manual lymphatic drainage therapy was administered in the afternoon of the same day by a professional physiotherapist using the "Vodder" technique. In this study, measurements were conducted by two researchers. Swelling and trismus values were recorded preoperatively (T0), on the 3rd postoperative day (T1), and on the 7th postoperative day (T2). To assess pain, the VAS was used and values were recorded 1, 2, 3 and 7 days postoperatively. In this study, edema was evaluated using the 3dMD FACE SYSTEM (3dMD, Atlanta, GA), which virtually transfers the patient's face into 3D, allowing for the calculation of volume changes.To assess pain, the Visual Analog Scale (VAS) was used.To determine the effect of MLD therapy on postoperative trismus, the distance between the upper and lower incisors was measured using a digital caliper immediately before the operation, as well as on the 3rd and 7th postoperative days
- Conditions
- Impacted Third Molar Tooth, Swelling/ Edema, Pain, Trismus
- Being tested
- Manual Lymphatic Drainage technique, Conventional Treatment group
- Keywords
- impacted lower third molar, 3dMD, Manual Lymphatic Drainage, edema
- Medical subject headings
- Edema, Pain, Trismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual Lymphatic Drainage techniqueProcedure or surgery
Following the morning surgery, manual lymphatic drainage therapy was administered in the afternoon of the same day by a professional physiotherapist.
Conventional Treatment groupProcedure or surgery
patients were prescribed antibiotics (amoxicillin with clavulanic acid, 1 g, twice daily), analgesics (paracetamol, 500 mg, twice daily), and mouthwash (chlorhexidine gluconate, three times daily) for five days. Cold application was recommended to all patients.
| Study group | Role | What they receive |
|---|---|---|
| Manual Lymphatic Drainage technique | Experimental | Following the morning surgery, MLD therapy was administered in the afternoon of the same day by a professional physiotherapist Receives: Procedure: Manual Lymphatic Drainage technique; Procedure: Conventional Treatment group |
| Conventional treatment | Experimental | Postoperatively, patients were prescribed antibiotics (amoxicillin with clavulanic acid, 1 g, twice daily), analgesics (paracetamol, 500 mg, twice daily), and mouthwash (chlorhexidine gluconate, three times daily) for five days. Receives: Procedure: Manual Lymphatic Drainage technique; Procedure: Conventional Treatment group |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative facial swelling
Facial swelling
T0-T1 and T0-T2 scans are opened and superimposed through three reference points:
endocanthion left (inner most point on commissure of left eye fissure), endocanthion right (inner most point on commissure of right eye fissure) and subnasale (mid point of columella).
After matching, the swelling was calculated by selecting the area of the swelling and subtracting the two images.
Measured: one week
Secondary outcomes (2)
Pain
VAS measure
Measured: one week
Mouth opening
measurement of the maximal distance between the cutting edge of the right maxillary and right mandibular central incisors with a caliper.
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start1 Mar 2018
- Primary completion1 Sep 2018
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Impacted Third Molar ToothStudies 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
- Model description
- Split-mouth model
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Onur ŞAHİN, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06787027
- Sponsor's protocol ID
- 19
- Acronym
- wisdom tooth
- Status last verified
- Jan 2025
- First submitted
- 16 Jan 2025
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ulu M, Unal N, Sahin O, Kayali Y. Evaluation of the effect of manual lymphatic drainage method on edema, pain and trismus after impacted bilateral mandibular third molar surgery: a randomized clinical trial. BMC Oral Health. 2025 Mar 26;25(1):438. doi: 10.1186/s12903-025-05817-6.
PubMed 40140780
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Manual Lymphatic Drainage Method on Edema, Pain and Trismus After Impacted Bilateral Mandibular Third Molar Surgery: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06787027
- Acronym / sponsor ID
- wisdom tooth / 19
- Conditions
- Impacted Third Molar Tooth, Swelling/ Edema, Pain, Trismus
- Keywords
- impacted lower third molar, 3dMD, Manual Lymphatic Drainage, edema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 22 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.
The aim of this study was to evaluate the effect of manual lymphatic drainage on pain, edema and trismus after impacted mandibular third molar surgery.
Detailed description
This study is a randomized controlled split-mouth trial. A total of 46 healthy patients who presented to our department for the extraction of impacted mandibular third molars were included in this study.The inclusion criteria were as follows: presence of pericoronal infection, no recent use of anti-inflammatory medications, symmetrical impactions on both sides, asymptomatic cases, and class 2, position B or C, vertical and mesioangular impactions. Impactions were classified using the Pell and Gregory classification system.
Exclusion criteria included patients who declined participation, pregnant or lactating individuals, patients with penicillin allergies, those with chronic diseases that could affect healing, uncooperative patients. Following the surgery, manual lymphatic drainage therapy was administered in the afternoon of the same day by a professional physiotherapist using the "Vodder" technique. In this study, measurements were conducted by two researchers. Swelling and trismus values were recorded preoperatively (T0), on the 3rd postoperative day (T1), and on the 7th postoperative day (T2). To assess pain, the VAS was used and values were recorded 1, 2, 3 and 7 days postoperatively. In this study, edema was evaluated using the 3dMD FACE SYSTEM (3dMD, Atlanta, GA), which virtually transfers the patient's face into 3D, allowing for the calculation of volume changes.To assess pain, the Visual Analog Scale (VAS) was used.To determine the effect of MLD therapy on postoperative trismus, the distance between the upper and lower incisors was measured using a digital caliper immediately before the operation, as well as on the 3rd and 7th postoperative days
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Split-mouth model
| Arm | Type | Receives |
|---|---|---|
| Manual Lymphatic Drainage technique | Experimental | Procedure: Manual Lymphatic Drainage technique, Procedure: Conventional Treatment groupFollowing the morning surgery, MLD therapy was administered in the afternoon of the same day by a professional physiotherapist |
| Conventional treatment | Experimental | Procedure: Manual Lymphatic Drainage technique, Procedure: Conventional Treatment groupPostoperatively, patients were prescribed antibiotics (amoxicillin with clavulanic acid, 1 g, twice daily), analgesics (paracetamol, 500 mg, twice daily), and mouthwash (chlorhexidine gluconate, three times daily) for five days. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- good general health conditions;
- presence of bilateral and symmetrical impacted third molars (according to the classifications of Winter and Pell and Gregory);
Key exclusion criteria (4 listed)
- no clinical evidence of major facial asymmetry;
- use of medication that would influence or alter wound healing;
- temporomandibular joint disorder history;
- smoking
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 |
|---|---|---|
| Manual Lymphatic Drainage techniqueFollowing the morning surgery, manual lymphatic drainage therapy was administered in the afternoon of the same day by a professional physiotherapist. | Procedure or surgery | Conventional treatment, Manual Lymphatic Drainage technique |
| Conventional Treatment grouppatients were prescribed antibiotics (amoxicillin with clavulanic acid, 1 g, twice daily), analgesics (paracetamol, 500 mg, twice daily), and mouthwash (chlorhexidine gluconate, three times daily) for five days. Cold application was recommended to all patients. | Procedure or surgery | Conventional treatment, Manual Lymphatic Drainage technique |
Primary outcome
postoperative facial swelling
Time frame: one week
Facial swelling T0-T1 and T0-T2 scans are opened and superimposed through three reference points: endocanthion left (inner most point on commissure of left eye fissure), endocanthion right (inner most point on commissure of right eye fissure) and subnasale (mid point of columella). After matching, the swelling was calculated by selecting the area of the swelling and subtracting the two images.
2 secondary outcomes
Pain
Time frame: one week
Mouth opening
Time frame: one week
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 22 Jan 2025.
- Derived from this study: PubMed 40140780Ulu M, Unal N, Sahin O, Kayali Y. Evaluation of the effect of manual lymphatic drainage method on edema, pain and trismus after impacted bilateral mandibular third molar surgery: a randomized clinical trial. BMC Oral Health. 2025 Mar 26;25(1):438. doi: 10.1186/s12903-025-05817-6.
- 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 Manual Lymphatic Drainage technique and Conventional Treatment group in people with Impacted Third Molar Tooth and Swelling/ Edema, run by Izmir Katip Celebi University 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 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 22 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?
postoperative facial swelling (time frame: one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06787027, which also lists 1 linked publication.
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 22 Jan 2025.