Laser Biostimulation in Periodontal Treatment

NCT04253613 | Completed

• 1 other identifier: OMU KAEK2012/49
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The use of nonsurgical periodontal treatment, together with plaque control is considered the gold standart for the treatment of periodontal diseases; it produces beneficial effects such as reductions in clinical inflammation, decreases in pocket depth and increases in clinical attachment levels .However to modulate the healing response additional protocols has been suggested to increase the efficacy of existing treatment protocols. Laser biostimulation therapy is highly preferred method used due to its healing acceleration effect on several wounds in medical field. Thus,the investigators aimed to evaluate the laser biostimulation therapy adjunct to non-surgical periodontal treatment in systemically healthy and uncontrolled type 2 diabetes mellitus patients with generalized periodontitis. The effects of laser irradiation with Nd-YAG laser at the 1064-nm wavelength as an adjunct to non-surgical periodontal treatment (NSPT) was analysed by means of IL-1β and IL-10 concentrations in gingival crevicular fluid and periodontal clinical measurements of systemically healthy and uncontroled DM2 patients with generalized periodontitis.

Conditions

Periodontal Inflammation; Periodontal Diseases

Keywords

periodontitis; diabetes mellitus; periodontal treatment; laser biostimulation therapy

Outcome Measures

Primary Outcomes (2)

• IL-1β level in GCF

  IL-1β is a cytokine present in gingival crevicular fluid (GCF). Its concentration is calculated as picogram/microliter and it changes due to the elimination of inflammation by periodontal therapy.

  GCF sampling was performed prior to periodontal treatment and on days 30,37,72 of follow-up.

• IL-10 level in GCF

  IL-10 is a cytokine present in gingival crevicular fluid (GCF). Its concentration is calculated as picogram/microliter and it changes due to the elimination of inflammation by periodontal therapy.

  GCF sampling was performed prior to periodontal treatment and on days 30,37,72 of follow-up.

Study Arms (4)

periodontal therapy

Systemically healthy subjects with periodontitis that have the sides treated with non-surgical periodontal treatment (NSPT) split-mouth designed study

periodontal+laser therapy

Systemically healthy subjects with periodontitis that have the contra-lateral sides treated with laser biostimulation therapy(LBT) adjunct to non-surgical periodontal treatment(NSPT) split-mouth designed study

diabetic periodontal therapy

Type 2 diabetic(DM2) subjects with periodontitis that have the sides treated with non-surgical periodontal treatment (NSPT) split-mouth designed study

diabetic periodontal+laser therapy

Type 2 diabetic(DM2) subjects with periodontitis that have the contra-lateral sides treated with laser biostimulation therapy(LBT) adjunct to non-surgical periodontal treatment (NSPT) split-mouth designed study

Eligibility Criteria

• Age: 35 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study was designed as a split-mouth, controlled, double-blind clinical study. Participants were recruited among patients admitted to the periodontology clinic in Ondokuz Mayıs university Dental Faculty. Periodontal status was assessed and diagnosed as generalized periodontitis. In the mouth of each patient in both diabetic and healthy population, two symmetrical teeth were assigned as one side to apply non-surgical periodontal treatment alone and the other side to apply laser biostimulation therapy adjunct to NSPT. Thus,15 diabetic and 15 systemically helathy subjects included in the split-mouth designed study and 4 groups were constituted as:periodontal therapy (n=15, Split-mouth); periodontal+laser therapy (n=15, Split-mouth); diabetic periodontal therapy (n=15, Split-mouth); diabetic periodontal+laser therapy(n=15, Split-mouth):

You may qualify if:

• Volunteering to participate in the study, being male and ≥ 35 years of age,
• Having been diagnosed as type 2 diabates mellitus (DM2) with the ADA criteria at least 2 years before the study and having an HbA1c value of ≥ 7 for DM2 group,
• Not having a systemic disease other than DM2 for diabetic group; and not having any systemical diseases for systemically healthy group,
• Not having any systemic complications of diabetes,
• Not smoking or consuming alcohol,
• Having at least 20 teeth,
• Having at least two single-rooted teeth (like one premolar or incisor tooth) representing symmetrical or same group teeth with gingival index≥2, bleeding on probing (+), probing pocket depth and/or clinical attachment lvel \>5 mm as well as ≥30% radiographically observable alveolar bone loss, on the left and right area of mandibular,
• Being able to fulfill the instructions for oral hygiene training

You may not qualify if:

• using systemic antimicrobials, non-steroidal anti-inflammatory drugs and/or steroids during the 6 weeks prior to data collection
• received periodontal treatment in the 6 months prior to data collection
• having predisposing factors such as a dental crown, bridge, filling, or cavity on teeth from which the GCF was to be collected.

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

MeSH Terms

Conditions

Periodontal Diseases; Periodontitis; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: February 5, 2020
• Study Start: January 15, 2013
• Primary Completion: June 15, 2014
• Study Completion: June 15, 2014
• Last Updated: July 6, 2022

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share