Impact of Photobiomodulation Bone Healing Following Cystic Enucleation

NCT ID: NCT06759571

Last Updated: 2025-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2024-12-10

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 .

Conditions

Maxillary Cyst

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

low level laser treatment

Intervention Type: PROCEDURE

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

Group B

About 10 patients who will undergo conventional surgical enucleation of intra-body maxillary cystic lesions.

Group Type: ACTIVE_COMPARATOR

low level laser treatment

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

Other Intervention Names

Maxillary cystic enucleation

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Minia University

OTHER

Sponsor Role: lead

Responsible Party

Tarek Abdelbarry

Lecturer of Oral and Maxillofacial Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

TAREK ABDELBARY, Lecturer

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry, Minia University

Locations

Faculty of Dentistry, Minia University

Minya, , Egypt

Countries

Egypt

Other Identifiers

Photobiomodulation

Identifier Type: -

Identifier Source: org_study_id