Impact of Photobiomodulation Bone Healing Following Cystic Enucleation

NCT06759571 | Completed DMC

• 1 other identifier: Photobiomodulation
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Maxillary Cyst

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Radiographic assessment

  From baseline to 3 and 6 months after the operation day

Study Arms (2)

Group A

ACTIVE COMPARATOR

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

Group B

ACTIVE COMPARATOR

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

Procedure: low level laser treatment

Interventions

low level laser treatment 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

Also known as: Maxillary cystic enucleation

Group A; Group B

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Faculty of Dentistry, Minia University

Minya, 2431412, Egypt

Location

Study Officials

• TAREK ABDELBARY, Lecturer

  Faculty of Dentistry, Minia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Oral and Maxillofacial Surgery

Study Record Dates

• First Submitted: December 28, 2024
• First Posted: January 6, 2025
• Study Start: February 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 10, 2024
• Last Updated: January 6, 2025

Record last verified: 2024-02

Locations

EG (1)