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Laser Biostimulation in Periodontal Treatment

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ClinicalTrials.gov Identifier: NCT04253613
Recruitment Status : Completed
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
muge lutfioglu, Ondokuz Mayıs University

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, we 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.

Condition or disease
Periodontal Inflammation Periodontal Diseases

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: LAaser Biostimulation in Periodontal Treatment of Diabetic and Systemically Healthy Periodontitis Patients
Actual Study Start Date : January 15, 2013
Actual Primary Completion Date : June 15, 2014
Actual Study Completion Date : June 15, 2014

Group/Cohort
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



Primary Outcome Measures :
  1. IL-1β level in GCF [ Time Frame: GCF sampling was performed prior to periodontal treatment and on days 30,37,72 of follow-up. ]
    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.

  2. IL-10 level in GCF [ Time Frame: GCF sampling was performed prior to periodontal treatment and on days 30,37,72 of follow-up. ]
    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.



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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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):
Criteria

Inclusion Criteria:

  1. Volunteering to participate in the study, being male and ≥ 35 years of age,
  2. 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,
  3. Not having a systemic disease other than DM2 for diabetic group; and not having any systemical diseases for systemically healthy group,
  4. Not having any systemic complications of diabetes,
  5. Not smoking or consuming alcohol,
  6. Having at least 20 teeth,
  7. 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,
  8. Being able to fulfill the instructions for oral hygiene training

Exclusion Criteria:

  1. using systemic antimicrobials, non-steroidal anti-inflammatory drugs and/or steroids during the 6 weeks prior to data collection
  2. received periodontal treatment in the 6 months prior to data collection
  3. having predisposing factors such as a dental crown, bridge, filling, or cavity on teeth from which the GCF was to be collected.
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Responsible Party: muge lutfioglu, Associate Professor, Ondokuz Mayıs University
ClinicalTrials.gov Identifier: NCT04253613    
Other Study ID Numbers: OMU KAEK2012/49
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by muge lutfioglu, Ondokuz Mayıs University:
periodontitis
diabetes mellitus
periodontal treatment
laser biostimulation therapy
Additional relevant MeSH terms:
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Periodontal Diseases
Inflammation
Pathologic Processes
Mouth Diseases
Stomatognathic Diseases