Third Molar ExtractionNCT05540015
Use of Erbium Laser for Extraction of the Third Molars
A study testing Third molar extraction by cutting and rotary tools and Third molar extraction by erbium laser with wavelength 2.94 nm in people with Third Molar Extraction and Impacted Third Molar Tooth, run by I.M. Sechenov First Moscow State Medical University.
Trial summary
A comparative analysis of the effectiveness of the erbium laser with the wavelength of 2.94 µm and traditional instruments in the extraction of the impacted lower third molars will be performed. Clinical, radiological and biochemical findings will be assessed after extraction of the impacted lower third molars. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Third Molar Extraction, Impacted Third Molar Tooth
- What is being tested?
- Third molar extraction by cutting and rotary tools and Third molar extraction by erbium laser with wavelength 2.94 nm
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Dec 2022to Aug 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 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signing of written informed consent of the patient to participate in a study
- Age from 25 to 50 years old
- Indications for impacted third molar extraction
- Patients who are medically stable
- Therapeutic and surgical oral hygiene before surgery (absence of inflammatory diseases, caries, pulpitis, periodontitis in oral cavity)
Who cannot join
- Refusal of the patient from further participation in the study
- Pregnancy diagnosed after the inclusion into the trial
- Non-compliance by the patient with postoperative recommendations
- Absence of a lower second molar
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Use of Erbium Laser With the Wavelength 2.94 nm for Extraction of the Impacted Lower Third Molars
A comparative analysis of the effectiveness of the erbium laser with the wavelength of 2.94 µm and traditional instruments in the extraction of the impacted lower third molars will be performed. Clinical, radiological and biochemical findings will be assessed after extraction of the impacted lower third molars.
Read the detailed description
A single-centre, interventional, non-randomized, prospective clinical trial in 2 parallel groups is planned. The lower third molars will be extracted in 60 patients. There will be 2 groups. The number of men and women in both groups will be the same, the patients age will be between 18 and 70 years. In the study group the lower third molars will be extracted using erbium laser with a wavelength of 2.94 µm (Erbium laser Smart 2940D plus with the wavelength 2,94 µm, company- DEKA, Italy, registration № 2005/1245), in the control group the lower third molars will be extracted using the conventional method (cutting and rotating instruments). Postoperative clinical symptoms such as collateral soft tissue swelling, postoperative pain, trismus in the extraction site and healing time (epithelization and bone regeneration) will be assessed. The epithelization will be assessed after 7, 10, 14 days. The bone regeneration will be assessed by cone beam computed tomography (KAVO, ORTHOPANTOMOGRAPH ОР 3D, type: РСХ-1; registration № РЗН 2020/10586) after 1, 3, 6 months. The radiation exposure will not exceed the permissible limits. Biochemical indicators in the saliva will be assessed before extraction, after extraction, 3 days and 7 days after the extraction. The Shapiro-Wilk test will be applied to check the normality of variable distribu- tion. Qualitative variables will be analyzed by Pearson's chi-squared test. Quantitative variables (normal distribution of variable) will be analyzed by Students t-test, non-normal distribution of variables will be analyzed by Mann-Whitney U test.
- Conditions
- Third Molar Extraction, Impacted Third Molar Tooth
- Being tested
- Third molar extraction by cutting and rotary tools, Third molar extraction by erbium laser with wavelength 2.94 nm
- Keywords
- Impacted third molars, Erbium laser, Atraumatic extraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Third molar extraction by cutting and rotary toolsProcedure or surgery
Extraction of the impacted lower third molar will be conducted using cutting and rotary tools under the local anesthesia (Ultracain D-S 1:100000 40 mg/ml, active substance- articaine+epinephrine, registration № П N015119/01 ). Scalpel will be used for the incision of the soft tissues, rotary instruments will be used for the bone tissue and tooth fragmentation. After the extraction the wound will be sutured by the suture material.
Third molar extraction by erbium laser with wavelength 2.94 nmProcedure or surgery
Extraction of the impacted lower third molar will be conducted using erbium laser with wavelength 2.94 nm under the local anesthesia (Ultracain D-S 1:100000 40 mg/ml, active substance- articaine+epinephrine, registration № П N015119/01 ). The soft tissue and bone tissue will be dissected by erbium laser with wavelength 2.94 µm (Erbium laser Smart 2940D plus with the wavelength 2,94 µm, company- DEKA, Italy, registration № 2005/1245). After the extraction the wound will be sutured by the suture material (registration № ФСЗ 2010/06040; 07.08.2018)
| Study group | Role | What they receive |
|---|---|---|
| Group with impacted third molar, extracted by cutting and rotary tools | Active comparator | The study group will include 28 patients with indications (impacted third molars that exerts pressure on the adjacent tooth and cause inflammation process in the surrounding tissue; absence of antagonist; pericorinitis; periodontitis; periodontal pockets) for the impacted third molar extraction. Patients will be comparable by gender and age, the patients age will be between 18 and 70 years. Patients should be with therapeutic and surgical oral hygiene and without co-morbidities. Receives: Procedure: Third molar extraction by cutting and rotary tools |
| Group with impacted third molar, extracted by erbium laser 2.94 nm | Active comparator | The study group will include 28 patients with indications (impacted third molars that exerts pressure on the adjacent tooth and cause inflammation process in the surrounding tissue; absence of antagonist; pericorinitis; periodontitis; periodontal pockets) for the impacted third molar extraction.Patients will be comparable by gender and age, the patients age will be between 18 and 70 years. Patients should be with therapeutic and surgical oral hygiene and without co-morbidities. Receives: Procedure: Third molar extraction by erbium laser with wavelength 2.94 nm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment the level of bone regeneration according to Radiographic bone height (RBH)
Assessment the level of bone regeneration according to Radiographic bone height (RBH) by cone beam computed tomography after extraction of the lower third molar. (Radiographic bone height (RBH)- is the distance between root apex of the distal root and uppermost intersecting point between distal root of the second molar and mesial wall of extraction socket, it will be measured on the cone beam computed tomography)
Measured: Days 180 after extraction
Secondary outcomes (14)
Radiographic bone height (RBH)
Assessment the level of bone regeneration according to Radiographic bone height (RBH) by cone beam computed tomography after extraction of the lower third molar with erbium laser. (Radiographic bone height (RBH)- is the distance between root apex of the distal root of the second molar and uppermost intersecting point between distal root of the second molar and mesial wall of extraction socket, it will be measured on the cone beam computed tomography)
Measured: 3;6 months
Radiographic infrabony defect (RID)
Assessment the level of bone regeneration according to Radiographic infrabony defect (RID) by cone beam computed tomography after extraction of the lower third molar with erbium laser. (Radiographic infrabony defect (RID) is the distance between cemento-enamel junction of the second molar and uppermost intersecting point between distal root of the second molar and mesial wall of extraction socket; it will be measured on the cone beam computed tomography)
Measured: 3;6 months
Post-operative pain
Post-operative pain will be assessed by 10-point visual analogue scale (VAS) in the area of the extracted tooth
Measured: 1;3;5;7;10 days
Post-operative oedema
Assessment the soft tissue epithelization using six-point Visual Analogue Scale (VAS) of swelling, where 0 indicates "no swelling", and 5 indicates "extreme severe swelling
Measured: 1;3;5;7;10 days
Soft tissue epithelization
Assessment the soft tissue epithelization using a photoprotocol (the day on which full tissue regeneration has taken place will be taken into account)
Measured: 7;10;14
Trismus
Assessment the distance between upper and lower incisors in mm
Measured: 1;3;5;7;10 days
sRANKL (soluble receptor activator of nuclear factor-κB ligand)
Assessment the level of sRANKL in saliva by enzyme-linked immunosorbent assay, ELISA
Measured: before surgery, after surgery, 3;7 days
OPG (osteoprotegerin)
Assessment the level of OPG in saliva by enzyme-linked immunosorbent assay, ELISA
Measured: before surgery, after surgery, 3;7 days
Fibroblast growth factor-b (FGF-b)
Assessment the level of FGF-b in saliva
Measured: before surgery, after surgery, 3;7 days
C-reactive protein (CRP)
Assessment the level of CRP in saliva by enzyme-linked immunosorbent assay
Measured: before surgery, after surgery, 3;7 days
IgA
Assessment the level of IgA in saliva by enzyme-linked immunosorbent assay
Measured: before surgery, after surgery, 3;7 days
IgG
Assessment the level of IgG in saliva by enzyme-linked immunosorbent assay
Measured: before surgery, after surgery, 3;7 days
IgM
Assessment the level of IgM in saliva by enzyme-linked immunosorbent assay
Measured: before surgery, after surgery, 3;7 days
Vascular endothelial growth factor (VEGF)
Assessment the level of VEGF in saliva by enzyme-linked immunosorbent assay
Measured: before surgery, after surgery, 3;7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study startDec 2022 (estimated)
- Primary completionAug 2024 (estimated)
- Study completionAug 2025 (estimated)
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diana Sologova, Principal investigator, I.M. Sechenov First Moscow State Medical University (Sechenov University)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05540015
- Sponsor's protocol ID
- 6482963527
- Status last verified
- Sep 2022
- First submitted
- 9 Sep 2022
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No, dissemination of data is prohibited by the local ethics committee
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Erbium Laser With the Wavelength 2.94 nm for Extraction of the Impacted Lower Third Molars
- ClinicalTrials.gov ID
- NCT05540015
- Acronym / sponsor ID
- 6482963527
- Conditions
- Third Molar Extraction, Impacted Third Molar Tooth
- Keywords
- Impacted third molars, Erbium laser, Atraumatic extraction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- Dec 2022 (estimated)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 14 Sep 2022 (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.
A comparative analysis of the effectiveness of the erbium laser with the wavelength of 2.94 µm and traditional instruments in the extraction of the impacted lower third molars will be performed. Clinical, radiological and biochemical findings will be assessed after extraction of the impacted lower third molars.
Detailed description
A single-centre, interventional, non-randomized, prospective clinical trial in 2 parallel groups is planned. The lower third molars will be extracted in 60 patients. There will be 2 groups. The number of men and women in both groups will be the same, the patients age will be between 18 and 70 years. In the study group the lower third molars will be extracted using erbium laser with a wavelength of 2.94 µm (Erbium laser Smart 2940D plus with the wavelength 2,94 µm, company- DEKA, Italy, registration № 2005/1245), in the control group the lower third molars will be extracted using the conventional method (cutting and rotating instruments). Postoperative clinical symptoms such as collateral soft tissue swelling, postoperative pain, trismus in the extraction site and healing time (epithelization and bone regeneration) will be assessed. The epithelization will be assessed after 7, 10, 14 days. The bone regeneration will be assessed by cone beam computed tomography (KAVO, ORTHOPANTOMOGRAPH ОР 3D, type: РСХ-1; registration № РЗН 2020/10586) after 1, 3, 6 months. The radiation exposure will not exceed the permissible limits. Biochemical indicators in the saliva will be assessed before extraction, after extraction, 3 days and 7 days after the extraction. The Shapiro-Wilk test will be applied to check the normality of variable distribu- tion. Qualitative variables will be analyzed by Pearson's chi-squared test. Quantitative variables (normal distribution of variable) will be analyzed by Students t-test, non-normal distribution of variables will be analyzed by Mann-Whitney U test.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group with impacted third molar, extracted by cutting and rotary tools | Active comparator | Procedure: Third molar extraction by cutting and rotary toolsThe study group will include 28 patients with indications (impacted third molars that exerts pressure on the adjacent tooth and cause inflammation process in the surrounding tissue; absence of antagonist; pericorinitis; periodontitis; periodontal pockets) for the impacted third molar extraction. Patients will be comparable by gender and age, the patients age will be between 18 and 70 years. Patients should be with therapeutic and surgical oral hygiene and without co-morbidities. |
| Group with impacted third molar, extracted by erbium laser 2.94 nm | Active comparator | Procedure: Third molar extraction by erbium laser with wavelength 2.94 nmThe study group will include 28 patients with indications (impacted third molars that exerts pressure on the adjacent tooth and cause inflammation process in the surrounding tissue; absence of antagonist; pericorinitis; periodontitis; periodontal pockets) for the impacted third molar extraction.Patients will be comparable by gender and age, the patients age will be between 18 and 70 years. Patients should be with therapeutic and surgical oral hygiene and without co-morbidities. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signing of written informed consent of the patient to participate in a study
- Age from 25 to 50 years old
- Indications for impacted third molar extraction
- Patients who are medically stable
- Therapeutic and surgical oral hygiene before surgery (absence of inflammatory diseases, caries, pulpitis, periodontitis in oral cavity)
Key exclusion criteria (4 listed)
- Refusal of the patient from further participation in the study
- Pregnancy diagnosed after the inclusion into the trial
- Non-compliance by the patient with postoperative recommendations
- Absence of a lower second molar
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 |
|---|---|---|
| Third molar extraction by cutting and rotary toolsExtraction of the impacted lower third molar will be conducted using cutting and rotary tools under the local anesthesia (Ultracain D-S 1:100000 40 mg/ml, active substance- articaine+epinephrine, registration № П N015119/01 ). Scalpel will be used for the incision of the soft tissues, rotary instruments will be used for the bone tissue and tooth fragmentation. After the extraction the wound will be sutured by the suture material. | Procedure or surgery | Group with impacted third molar, extracted by cutting and rotary tools |
| Third molar extraction by erbium laser with wavelength 2.94 nmExtraction of the impacted lower third molar will be conducted using erbium laser with wavelength 2.94 nm under the local anesthesia (Ultracain D-S 1:100000 40 mg/ml, active substance- articaine+epinephrine, registration № П N015119/01 ). The soft tissue and bone tissue will be dissected by erbium laser with wavelength 2.94 µm (Erbium laser Smart 2940D plus with the wavelength 2,94 µm, company- DEKA, Italy, registration № 2005/1245). After the extraction the wound will be sutured by the suture material (registration № ФСЗ 2010/06040; 07.08.2018) | Procedure or surgery | Group with impacted third molar, extracted by erbium laser 2.94 nm |
Primary outcome
Assessment the level of bone regeneration according to Radiographic bone height (RBH)
Time frame: Days 180 after extraction
Assessment the level of bone regeneration according to Radiographic bone height (RBH) by cone beam computed tomography after extraction of the lower third molar. (Radiographic bone height (RBH)- is the distance between root apex of the distal root and uppermost intersecting point between distal root of the second molar and mesial wall of extraction socket, it will be measured on the cone beam computed tomography)
14 secondary outcomes
Radiographic bone height (RBH)
Time frame: 3;6 months
Radiographic infrabony defect (RID)
Time frame: 3;6 months
Post-operative pain
Time frame: 1;3;5;7;10 days
Post-operative oedema
Time frame: 1;3;5;7;10 days
Soft tissue epithelization
Time frame: 7;10;14
Trismus
Time frame: 1;3;5;7;10 days
sRANKL (soluble receptor activator of nuclear factor-κB ligand)
Time frame: before surgery, after surgery, 3;7 days
OPG (osteoprotegerin)
Time frame: before surgery, after surgery, 3;7 days
Fibroblast growth factor-b (FGF-b)
Time frame: before surgery, after surgery, 3;7 days
C-reactive protein (CRP)
Time frame: before surgery, after surgery, 3;7 days
IgA
Time frame: before surgery, after surgery, 3;7 days
IgG
Time frame: before surgery, after surgery, 3;7 days
IgM
Time frame: before surgery, after surgery, 3;7 days
Vascular endothelial growth factor (VEGF)
Time frame: before surgery, after surgery, 3;7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
- Individual participant dataSharing planned: No. No, dissemination of data is prohibited by the local ethics committee
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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.
Diana Sologova principal investigator
I.M. Sechenov First Moscow State Medical University (Sechenov University)
Questions about this trial
What is this clinical trial studying?
A study testing Third molar extraction by cutting and rotary tools and Third molar extraction by erbium laser with wavelength 2.94 nm in people with Third Molar Extraction and Impacted Third Molar Tooth, run by I.M. Sechenov First Moscow State Medical University.
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 5 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: status not confirmed, as of the sponsor's last update on 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Svetlana Tarasenko (+7-985-773-48-53, tarasenko_s_v@staff.sechenov.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment the level of bone regeneration according to Radiographic bone height (RBH) (time frame: Days 180 after extraction). 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 14 Sep 2022.