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Use of Erbium Laser for Extraction of the Third Molars

Primary Purpose

Third Molar Extraction, Impacted Third Molar Tooth

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Third molar extraction by cutting and rotary tools
Third molar extraction by erbium laser with wavelength 2.94 nm
Sponsored by
I.M. Sechenov First Moscow State Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Third Molar Extraction focused on measuring Impacted third molars, Erbium laser, Atraumatic extraction

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Signing of written informed consent of the patient to participate in a study
  2. Age from 25 to 50 years old
  3. Indications for impacted third molar extraction
  4. Patients who are medically stable
  5. Therapeutic and surgical oral hygiene before surgery (absence of inflammatory diseases, caries, pulpitis, periodontitis in oral cavity)

Exclusion Criteria:

  1. Refusal of the patient from further participation in the study
  2. Pregnancy diagnosed after the inclusion into the trial
  3. Non-compliance by the patient with postoperative recommendations
  4. Absence of a lower second molar

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Group with impacted third molar, extracted by cutting and rotary tools

    Group with impacted third molar, extracted by erbium laser 2.94 nm

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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)

    Secondary Outcome Measures

    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)
    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)
    Post-operative pain
    Post-operative pain will be assessed by 10-point visual analogue scale (VAS) in the area of the extracted tooth
    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
    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)
    Trismus
    Assessment the distance between upper and lower incisors in mm
    sRANKL (soluble receptor activator of nuclear factor-κB ligand)
    Assessment the level of sRANKL in saliva by enzyme-linked immunosorbent assay, ELISA
    OPG (osteoprotegerin)
    Assessment the level of OPG in saliva by enzyme-linked immunosorbent assay, ELISA
    Fibroblast growth factor-b (FGF-b)
    Assessment the level of FGF-b in saliva
    C-reactive protein (CRP)
    Assessment the level of CRP in saliva by enzyme-linked immunosorbent assay
    IgA
    Assessment the level of IgA in saliva by enzyme-linked immunosorbent assay
    IgG
    Assessment the level of IgG in saliva by enzyme-linked immunosorbent assay
    IgM
    Assessment the level of IgM in saliva by enzyme-linked immunosorbent assay
    Vascular endothelial growth factor (VEGF)
    Assessment the level of VEGF in saliva by enzyme-linked immunosorbent assay

    Full Information

    First Posted
    September 9, 2022
    Last Updated
    September 9, 2022
    Sponsor
    I.M. Sechenov First Moscow State Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05540015
    Brief Title
    Use of Erbium Laser for Extraction of the Third Molars
    Official Title
    Use of Erbium Laser With the Wavelength 2.94 nm for Extraction of the Impacted Lower Third Molars
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2022 (Anticipated)
    Primary Completion Date
    August 2024 (Anticipated)
    Study Completion Date
    August 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    I.M. Sechenov First Moscow State Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Third Molar Extraction, Impacted Third Molar Tooth
    Keywords
    Impacted third molars, Erbium laser, Atraumatic extraction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group with impacted third molar, extracted by cutting and rotary tools
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Group with impacted third molar, extracted by erbium laser 2.94 nm
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Third molar extraction by cutting and rotary tools
    Intervention Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Third molar extraction by erbium laser with wavelength 2.94 nm
    Intervention Description
    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)
    Primary Outcome Measure Information:
    Title
    Assessment the level of bone regeneration according to Radiographic bone height (RBH)
    Description
    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)
    Time Frame
    Days 180 after extraction
    Secondary Outcome Measure Information:
    Title
    Radiographic bone height (RBH)
    Description
    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)
    Time Frame
    3;6 months
    Title
    Radiographic infrabony defect (RID)
    Description
    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)
    Time Frame
    3;6 months
    Title
    Post-operative pain
    Description
    Post-operative pain will be assessed by 10-point visual analogue scale (VAS) in the area of the extracted tooth
    Time Frame
    1;3;5;7;10 days
    Title
    Post-operative oedema
    Description
    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
    Time Frame
    1;3;5;7;10 days
    Title
    Soft tissue epithelization
    Description
    Assessment the soft tissue epithelization using a photoprotocol (the day on which full tissue regeneration has taken place will be taken into account)
    Time Frame
    7;10;14
    Title
    Trismus
    Description
    Assessment the distance between upper and lower incisors in mm
    Time Frame
    1;3;5;7;10 days
    Title
    sRANKL (soluble receptor activator of nuclear factor-κB ligand)
    Description
    Assessment the level of sRANKL in saliva by enzyme-linked immunosorbent assay, ELISA
    Time Frame
    before surgery, after surgery, 3;7 days
    Title
    OPG (osteoprotegerin)
    Description
    Assessment the level of OPG in saliva by enzyme-linked immunosorbent assay, ELISA
    Time Frame
    before surgery, after surgery, 3;7 days
    Title
    Fibroblast growth factor-b (FGF-b)
    Description
    Assessment the level of FGF-b in saliva
    Time Frame
    before surgery, after surgery, 3;7 days
    Title
    C-reactive protein (CRP)
    Description
    Assessment the level of CRP in saliva by enzyme-linked immunosorbent assay
    Time Frame
    before surgery, after surgery, 3;7 days
    Title
    IgA
    Description
    Assessment the level of IgA in saliva by enzyme-linked immunosorbent assay
    Time Frame
    before surgery, after surgery, 3;7 days
    Title
    IgG
    Description
    Assessment the level of IgG in saliva by enzyme-linked immunosorbent assay
    Time Frame
    before surgery, after surgery, 3;7 days
    Title
    IgM
    Description
    Assessment the level of IgM in saliva by enzyme-linked immunosorbent assay
    Time Frame
    before surgery, after surgery, 3;7 days
    Title
    Vascular endothelial growth factor (VEGF)
    Description
    Assessment the level of VEGF in saliva by enzyme-linked immunosorbent assay
    Time Frame
    before surgery, after surgery, 3;7 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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) Exclusion Criteria: 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Svetlana Tarasenko
    Phone
    +7-985-773-48-53
    Email
    tarasenko_s_v@staff.sechenov.ru
    First Name & Middle Initial & Last Name or Official Title & Degree
    Diana Sologova
    Phone
    +7-919-997-57-81
    Email
    sologova_d_i@student.sechenov.ru
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Diana Sologova
    Organizational Affiliation
    I.M. Sechenov First Moscow State Medical University (Sechenov University)
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    No, dissemination of data is prohibited by the local ethics committee

    Learn more about this trial

    Use of Erbium Laser for Extraction of the Third Molars

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