Impact of Photobiomodulation Bone Healing Following Cystic Enucleation

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

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

Study Overview

• Status: Completed
• Conditions: Maxillary Cyst
• Intervention / Treatment: Procedure: low level laser treatment

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Minya, Egypt, 2431412
    • Faculty of dentistry, Minia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; About 10 patients who will be subjected to low intensity diode laser "soft-laser SL202" ("PERTO LASER", pr. Stachek, 47, Saint Petersburg, Russia) before surgery (two times / week for two weeks) and then following surgery (for three times per week for four weeks).	Procedure: low level laser treatment; to evaluate the effect of low-level laser therapy (LLLT) bone healing when used prior and following enucleation of intra-body maxillary cystic lesions; Other Names: Maxillary cystic enucleation
Active Comparator: Group B; About 10 patients who will undergo conventional surgical enucleation of intra-body maxillary cystic lesions.	Procedure: low level laser treatment; to evaluate the effect of low-level laser therapy (LLLT) bone healing when used prior and following enucleation of intra-body maxillary cystic lesions; Other Names: Maxillary cystic enucleation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post- operative pain assessment	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)	From First 24 hours after The procedure till 7 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Minia University
• Investigators: Principal Investigator: TAREK ABDELBARY, Lecturer, Faculty of dentistry, Minia University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Actual): December 1, 2024
• Study Completion (Actual): December 10, 2024

Study Registration Dates

• First Submitted: December 28, 2024
• First Submitted That Met QC Criteria: December 28, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Photobiomodulation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No