Effect of Low-Level Laser on Crevicular Interleukin-1β Concentration in Patients With Periodontal Disease: A Relation to Periodontal Inflammaging

NCT06677385 | Completed FDA Device

• 1 other identifier: 2022/0082
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This study is done to compare between young age and old age patients with periodontitis (inflammaging) and the effect of diode laser as adjunctive to scaling and debridement

Conditions

Periodontal Diseases; Old Age

Outcome Measures

Primary Outcomes (3)

• Gingival index

  first visit, second follow up after 1 month and final follow up after 6 months

• Clinical attachment loss

  first visit, second follow up after 1 month and final follow up after 6 months

• Interleukin 1 beta

  collected and analyzed by ELISA from Gingival crevicular fluid and blood serum

  first visit, second follow up after 1 month and final follow up after 6 months

Study Arms (4)

Conventional scaling and debridement in young aged patients

EXPERIMENTAL

scaling and debridement

Procedure: conventional scaling and debridement

Conventional scaling and debridement of old aged patients

EXPERIMENTAL

Procedure: conventional scaling and debridement

diode laser as adjunctive to conventional scaling and debridement for old age patients

EXPERIMENTAL

Radiation: diode laser as adjunctive to conventional scaling and debridement

diode laser as adjunctive to conventional scaling and debridement for young age patients

EXPERIMENTAL

Radiation: diode laser as adjunctive to conventional scaling and debridement

Interventions

diode laser as adjunctive to conventional scaling and debridement RADIATION

diode laser as adjunctive to conventional scaling and debridement for old age patients

diode laser as adjunctive to conventional scaling and debridement for old age patients; diode laser as adjunctive to conventional scaling and debridement for young age patients

conventional scaling and debridement PROCEDURE

conventional scaling and debridement

Conventional scaling and debridement in young aged patients; Conventional scaling and debridement of old aged patients

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female
• Aged below 40 or above 60.
• Provide informed consent and willingness to cooperate with study protocol.
• Periodontitis stage II patients:
• CAL from 3-4 mm.
• Radiographic bone loss (15% to 33%).
• No tooth loss due to periodontitis.
• Maximum probing depth ≤ 5 mm, mostly horizontal bone loss

You may not qualify if:

• Patients with heavy smoking habits
• History of antibiotics in the previous three months.
• Pregnant or lactating female.
• Treatment with any systemic drug.
• History of systemic disease.
• Patients who received periodontal treatment in the last 6 months

Sponsors & Collaborators

• Misr University for Science and Technology: lead

Study Sites (1)

Misr University foe Science and Technology

Giza, Giza Governorate, 0000, Egypt

Location

MeSH Terms

Conditions

Periodontal Diseases

Interventions

Lasers, Semiconductor; Debridement

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching assistant

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 6, 2024
• Study Start: July 12, 2023
• Primary Completion: March 12, 2024
• Study Completion: October 12, 2024
• Last Updated: February 26, 2025

Record last verified: 2024-11

Locations

EG (1)