Impacted Third Molar Tooth Clinical Trial
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.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | August 2025 |
Est. primary completion date | August 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 25 Years to 70 Years |
Eligibility | 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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I.M. Sechenov First Moscow State Medical University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | Days 180 after extraction | |
Secondary | 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) | 3;6 months | |
Secondary | 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) | 3;6 months | |
Secondary | Post-operative pain | Post-operative pain will be assessed by 10-point visual analogue scale (VAS) in the area of the extracted tooth | 1;3;5;7;10 days | |
Secondary | 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 | 1;3;5;7;10 days | |
Secondary | 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) | 7;10;14 | |
Secondary | Trismus | Assessment the distance between upper and lower incisors in mm | 1;3;5;7;10 days | |
Secondary | sRANKL (soluble receptor activator of nuclear factor-?B ligand) | Assessment the level of sRANKL in saliva by enzyme-linked immunosorbent assay, ELISA | before surgery, after surgery, 3;7 days | |
Secondary | OPG (osteoprotegerin) | Assessment the level of OPG in saliva by enzyme-linked immunosorbent assay, ELISA | before surgery, after surgery, 3;7 days | |
Secondary | Fibroblast growth factor-b (FGF-b) | Assessment the level of FGF-b in saliva | before surgery, after surgery, 3;7 days | |
Secondary | C-reactive protein (CRP) | Assessment the level of CRP in saliva by enzyme-linked immunosorbent assay | before surgery, after surgery, 3;7 days | |
Secondary | IgA | Assessment the level of IgA in saliva by enzyme-linked immunosorbent assay | before surgery, after surgery, 3;7 days | |
Secondary | IgG | Assessment the level of IgG in saliva by enzyme-linked immunosorbent assay | before surgery, after surgery, 3;7 days | |
Secondary | IgM | Assessment the level of IgM in saliva by enzyme-linked immunosorbent assay | before surgery, after surgery, 3;7 days | |
Secondary | Vascular endothelial growth factor (VEGF) | Assessment the level of VEGF in saliva by enzyme-linked immunosorbent assay | before surgery, after surgery, 3;7 days |
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