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Impact of Photobiomodulation Bone Healing Following Cystic Enucleation

Impact of Photobiomodulation Bone Healing Following Cystic Enucleation: A Randomized Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06759571
Enrollment
20
Registered
2025-01-06
Start date
2024-02-01
Completion date
2024-12-10
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maxillary Cyst

Brief summary

A well-known issues confronted by oral and maxillofacial specialists are the osseous defects and dead spaces and how can be obliterated and augmented in the facial regions. Unerupted tooth and bone loss after its removal, remaining roots and enucleation of cysts; all of which makes prosthetic rehabilitation and implant application more complicated

Detailed description

Bone is undergoes remodeling via cycles of bone resorption and bone formation which is considered a mineralized connective tissue, an inflammatory immune reaction which is triggered by local injury which is thought to highly influence the outcome of the bone healing process. Low-Level Laser Therapy (LLLT) is a form of phototherapy that involves the application of low power monochromatic and coherent light to areas of injuries and lesions. It has been shown to induce wound healing in non-healing bone defects . Bone healing is a multidimensional process of reconstruction of the bone tissue with an overlapping timeline. Because of the regeneration ability of the bone, bone defects can heal spontaneously under suitable physiological environmental conditions. The healing process of the bone defect is time consuming, and new bone generation takes place slowly because of diminished of blood supply to the defect site and insufficiency of calcium and phosphorus to strengthen and harden new bone. The low-level laser therapy (LLLT) has a positive effect on bone tissue metabolism . Moreover it is beneficial for the initial stages of alveolar bone healing and for further calcification; An experimental animal study in both diabetic and normal rats under histological observations and gene expression analyses have confirmed this when applied at a dose of 13.95 J/cm2 for 60 sec .

Interventions

to evaluate the effect of low-level laser therapy (LLLT) bone healing when used prior and following enucleation of intra-body maxillary cystic lesions

Sponsors

Minia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

\- patients (class I category according to American society of anesthesiologists) over 20 years and under 50 years of age, of either gender who are seeking cyst enucleation of painful intra-body maxillary cystic lesions 3 x 4 cm in size.

Exclusion criteria

* any systemic disease that interferes with bone healing, * patients with significant medical condition, * alcoholic individuals, * patients on drugs that affect the central nervous systems, * patients who reported the use of drugs that might interfere with pain sensitivity * pregnancy, * lactation

Design outcomes

Primary

MeasureTime frameDescription
Post- operative pain assessmentFrom First 24 hours after The procedure till 7 daysPain scores will be recorded on visual analog scale (VAS) using a 0 to 10 pain score basis with 0 being no pain and 10 being the worst pain the patient had ever experienced.(record will be every 24h for 7 days)

Secondary

MeasureTime frameDescription
Radiographic assessmentFrom baseline to 3 and 6 months after the operation dayCBCT (Planmeca. Promax 3DMid machine, Helsinki Finland) scan will be obtained immediately post-operative, 3 and 6 months postoperative.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026