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IRCT20260515069406N1 IRCT 2026-06-18 Shahid Beheshti University of Medical Sciences Effect of low level laser therapy in prevention of MRONJ after tooth extraction Investigating the effect of low-level laser therapy in preventing Osteonecrosis of the jaws in patients with a history of taking Bisphosphonate and Denosumab drugs after tooth extraction 2026-06-22 anticipated 30 Complete https://irct.ir/trial/90151 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Prevention. N/A Medication Related Osteonecrosis Of Jaws ( MRONJ). Intervention group: The target population of this study is divided into two groups:1- Patients who have been taking oral bisphosphonates (sodium Alendronate) for more than three years due to osteoporosis or who have used the injectable form of denosumab ( Prolia or Xgeva) .2- Specific patients who are undergoing intravenous bisphosphonate (Zoledronic acid ) or Denosumab treatment by an oncologist due to bone metastases or bone marrow cancer such as multiple myeloma even one single dose.These patients undergo a low-level laser protocol before and after extraction of non-retainable teeth, and the process of soft and hard tissue repair is studied.A drug holiday of at least two months is also considered in patients. The patient will take oral antibiotic amoxicillin 500 mg every eight hours from three days before tooth extraction until soft tissue recovery. The patient will also use 0.2% chlorhexidine mouthwash for a period of time. At least two laser therapy sessions before extraction and then eight post-extraction laser therapy sessions continue in the dental socket in the laser department of faculty , as sessions twice a week. If the patient requires additional sessions, additional sessions can be continued until the soft tissue is fully recovered.The Diode laser available in the Faculty of Dentistry has a wavelength of 808 nm and a power of 0.4 watts (LAMBDA Scientifica Company under the trade name Doctor Smile) with a continuous radiation mode for 60 seconds from the buccal, lingual (palatal) and occlusal areas on the surface of the tooth or tooth socket in a non-contact manner. The photosensitizer methylene blue is used in this study to utilize photodynamic therapy to reduce bacterial load. The patient is visited by residents every week after laser therapy and photographs of the socket are taken to check the healing process, meaning the patient is followed up from one week after extraction to one month later. Then, a 4-month follow-up with appropriate radiographs is also performed to check for bone healing.. Yes - There is a plan to make this available What will be shared: The type of illness of the person and the history of the medication used, drug holiday , and photography of the extracted socket that show the healing process on a weekly basis until complete healing, can be published. When: Access begins 6 months after results are published. To whom: Researchers working in academic and scientific institutions Conditions: For better results and broader research in the field of MRONJ, anyone who has research on the prevention and treatment of this disease, which is a complication after tooth extraction in patients taking certain drugs such as bisphosphonates and denosumab, can request access to the data. Where to obtain: Hoda Movafagh Moghadam Tehran, Oral and Maxillofacial Surgery Department, College of Dentistry, Shahid Beheshti University EMAIL: hoda. movafagh63@gmail.com How to obtain: This research is the subject of my thesis for my specialization course, a copy of which will be available at Shahid Beheshti Dental School after the defense. The applicant should first submit the request to me via email, and then coordination will be provided for access. Comments:
public Hoda Movafagh Moghadam
No36, East Sonbol Ave., South Golestan Ave. Ferdos Blvd, 2nd Sadeghiyeh SQ
Tehran Iran (Islamic Republic of) 1481754553 +98 21 4400 0421 hoda.movafagh63@gmail.com Shahid Beheshti University of Medical Sciences scientific Hoda Movafagh Moghadam
No.36,East Sonbol Alley, South Golestan Ave. Ferdos Blvd,2nd Sadeghiyeh SQ
Tehran Iran (Islamic Republic of) 1481754553 +98 21 4400 0421 hoda.movafagh63@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) patient with history of Bisphosphonate therapy (orally or parenteral) in need of extraction of hopeless tooth no limit no limit Both severe systemic problem which prevents tooth extraction and causes exclusion of patient from laser therapy and tooth extraction Prevention Intervention group: The target population of this study is divided into two groups:1- Patients who have been taking oral bisphosphonates (sodium Alendronate) for more than three years due to osteoporosis or who have used the injectable form of denosumab ( Prolia or Xgeva) .2- Specific patients who are undergoing intravenous bisphosphonate (Zoledronic acid ) or Denosumab treatment by an oncologist due to bone metastases or bone marrow cancer such as multiple myeloma even one single dose.These patients undergo a low-level laser protocol before and after extraction of non-retainable teeth, and the process of soft and hard tissue repair is studied.A drug holiday of at least two months is also considered in patients. The patient will take oral antibiotic amoxicillin 500 mg every eight hours from three days before tooth extraction until soft tissue recovery. The patient will also use 0.2% chlorhexidine mouthwash for a period of time. At least two laser therapy sessions before extraction and then eight post-extraction laser therapy sessions continue in the dental socket in the laser department of faculty , as sessions twice a week. If the patient requires additional sessions, additional sessions can be continued until the soft tissue is fully recovered.The Diode laser available in the Faculty of Dentistry has a wavelength of 808 nm and a power of 0.4 watts (LAMBDA Scientifica Company under the trade name Doctor Smile) with a continuous radiation mode for 60 seconds from the buccal, lingual (palatal) and occlusal areas on the surface of the tooth or tooth socket in a non-contact manner. The photosensitizer methylene blue is used in this study to utilize photodynamic therapy to reduce bacterial load. The patient is visited by residents every week after laser therapy and photographs of the socket are taken to check the healing process, meaning the patient is followed up from one week after extraction to one month later. Then, a 4-month follow-up with appropriate radiographs is also performed to check for bone healing. Soft tissue healing and wound closure over the extracted dental socket. Timepoint: Weekly clinical examination until complete healing of soft tissue. Method of measurement: Weekly clinical observation and examination and recording by camera photography. Hard tissue healing in extracted dental socket. Timepoint: Radiographic examination 4 months after tooth extraction. Method of measurement: Panoramic or periapical radiographic examination. Shahid Beheshti University of Medical Sciences Approved 2025-07-26 Ethics committee of Shahid Beheshti University of Medical Science No.36, East Sonbol alley,South Golestan ave,Ferdos blvd, 2nd Sadeghiyeh SQ Tehran Tehran Iran (Islamic Republic of)