Impacted Third Molar Tooth, Third Molar Extraction
Conditions
Keywords
Impacted third molars, Erbium laser, Atraumatic extraction
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.
Interventions
PROCEDUREThird molar extraction by cutting and rotary tools
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.
PROCEDUREThird molar extraction by erbium laser with wavelength 2.94 nm
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)
Sponsors
I.M. Sechenov First Moscow State Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment the level of bone regeneration according to Radiographic bone height (RBH) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic infrabony defect (RID) | 3;6 months | 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 | 1;3;5;7;10 days | Post-operative pain will be assessed by 10-point visual analogue scale (VAS) in the area of the extracted tooth |
| Post-operative oedema | 1;3;5;7;10 days | 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 | 7;10;14 | Assessment the soft tissue epithelization using a photoprotocol (the day on which full tissue regeneration has taken place will be taken into account) |
| Trismus | 1;3;5;7;10 days | Assessment the distance between upper and lower incisors in mm |
| sRANKL (soluble receptor activator of nuclear factor-κB ligand) | before surgery, after surgery, 3;7 days | Assessment the level of sRANKL in saliva by enzyme-linked immunosorbent assay, ELISA |
| Radiographic bone height (RBH) | 3;6 months | 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) |
| Fibroblast growth factor-b (FGF-b) | before surgery, after surgery, 3;7 days | Assessment the level of FGF-b in saliva |
| C-reactive protein (CRP) | before surgery, after surgery, 3;7 days | Assessment the level of CRP in saliva by enzyme-linked immunosorbent assay |
| IgA | before surgery, after surgery, 3;7 days | Assessment the level of IgA in saliva by enzyme-linked immunosorbent assay |
| IgG | before surgery, after surgery, 3;7 days | Assessment the level of IgG in saliva by enzyme-linked immunosorbent assay |
| IgM | before surgery, after surgery, 3;7 days | Assessment the level of IgM in saliva by enzyme-linked immunosorbent assay |
| Vascular endothelial growth factor (VEGF) | before surgery, after surgery, 3;7 days | Assessment the level of VEGF in saliva by enzyme-linked immunosorbent assay |
| OPG (osteoprotegerin) | before surgery, after surgery, 3;7 days | Assessment the level of OPG in saliva by enzyme-linked immunosorbent assay, ELISA |
Contacts
Primary ContactSvetlana Tarasenko
Backup ContactDiana Sologova
Outcome results
None listed