Clinical trial NCT06759571: Impact of Photobiomodulation Bone Healing Following Cystic Enucleation
Official title: Impact of Photobiomodulation Bone Healing Following Cystic Enucleation: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maxillary Cyst
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2025-01-06
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .

Eligibility criteria: 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

Primary outcomes:
measure: Post- operative pain assessment
timeFrame: From First 24 hours after The procedure till 7 days
Secondary outcomes:
measure: Radiographic assessment
timeFrame: From baseline to 3 and 6 months after the operation day
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Faculty of Dentistry, Minia University
Study officials:
affiliation: Faculty of Dentistry, Minia University
name: TAREK ABDELBARY, Lecturer
role: PRINCIPAL_INVESTIGATOR
References: