Impact of Photobiomodulation Bone Healing Following Cystic Enucleation

Not Applicable

Completed

• Conditions: Maxillary Cyst

• Registration Number: NCT06759571
• Lead Sponsor: Minia University

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 .

Study Timeline

• Status Verified: 2024-02
• Study Start: 2024-02-01
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-10
• Study First Submitted: 2024-12-28
• Study First Submitted QC: 2024-12-28
• Last Update Submitted: 2024-12-28
• Study First Posted: 2025-01-06
• Last Update Posted: 2025-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Post- operative pain assessment	From First 24 hours after The procedure till 7 days	Pain 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 Outcome Measures

Name	Time	Method
Radiographic assessment	From baseline to 3 and 6 months after the operation day	CBCT (Planmeca. Promax 3DMid machine, Helsinki Finland) scan will be obtained immediately post-operative, 3 and 6 months postoperative.

Trial Locations

Locations (1)

Faculty of Dentistry, Minia University; 🇪🇬 Minya, Egypt