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Diode Laser With Periodontal Flap Surgery in Periodontitis

Primary Purpose

Periodontitis, Aggressive, Diode Laser Therapy, Periodontal Diseases

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Diode Laser
Modified Widman Flap
Sponsored by
Bulent Ecevit University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis, Aggressive focused on measuring diode laser, aggressive periodontitis, Modified Widman Flap, microbiology

Eligibility Criteria

22 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The inclusion criteria for stage 3-grade C periodontitis patients were interdental CAL ≥ 5 mm and PD ≥ 6 mm on at least 6 teeth and at least three of these six teeth were not molars or incisors.
  • They were under 35 years of age.
  • These patients had at least two quadrants of maxilla with three teeth each having CAL ≥ 5 mm and PD ≥ 6 mm.

Exclusion Criteria:

  • : systemic conditions such as; diabetes mellitus, cancer, cardiovascular and respiratory diseases,
  • current and ex-smoking habits,
  • undergone non-surgical periodontal therapy and prescription of antibiotics or non-steroidal anti-inflammatory medication within the previous 6 months or surgical periodontal treatment within the preceding year,
  • pregnancy, lactation, postmenopause, or immunologic disorders,

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Sham Comparator

    Arm Label

    Active Diode Laser Therapy+ Modified Widman Flap

    Sham Diode Laser Therapy+ Modified Widman Flap

    Arm Description

    Diode laser with a wavelength of 810±5 nm and a power of 1 watt in continuous mode was applied to the Modified Widman Flap at the test sites

    Control sites were treated with MWF alone

    Outcomes

    Primary Outcome Measures

    Clinical Attachment Level
    distance between the cemento-enamel junction to the deepest point of periodontal pocket

    Secondary Outcome Measures

    Probing depth
    distance between the gingival margin to the deepest point of periodontal pocket

    Full Information

    First Posted
    October 24, 2021
    Last Updated
    November 3, 2021
    Sponsor
    Bulent Ecevit University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05108727
    Brief Title
    Diode Laser With Periodontal Flap Surgery in Periodontitis
    Official Title
    Clinical and Microbiological Evaluation of Diode Laser- Assisted-Flap Surgery for the Treatment of Patients With Stage 3-Grade C Periodontitis: 6-month Randomized Split-mouth Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2013 (Actual)
    Primary Completion Date
    February 2016 (Actual)
    Study Completion Date
    March 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Bulent Ecevit University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The authors theorize that periodontal flap surgery therapy with adjunctive DL therapy might bring favourable therapy results (clinical and bacterial parameters) in patients with stage 3-grade C periodontitis. Therefore, the goal of this split-mouth randomized clinical trial was to evaluate and compare the effectiveness of the treatment results for DL assisted modified Widman Flap (MWF) surgery (test site) with MWF surgery alone (control site) in periodontitis patients with stage 3-grade C by determining the changes in clinical parameters and bacterial load of pathogens (P.g., T.d., Camplyobacter rectus (C.r.), Prevotella intermedia (P.i.), T.f., A.a.) at preoperative and following MWF surgery at 6th week, 3rd and 6th months
    Detailed Description
    A randomised control split-mouth study were performed at the Department of Periodontology, Faculty of Dentistry, Bülent Ecevit University, Zonguldak, Turkey, between January 2013 and February 2016.After clinical evaluation, a total of 30 subjects, who showed signs of stage 3-grade C periodontitis, were enrolled to this study at baseline. These patients were underwent a full mouth scaling and root planning (SRP). Six weeks after non surgical periodontal therapy, periodontal assessment was performed to confirm the suitability of the sites for periodontal surgery. This split-mouth study was conducted in 18 patients with stage 3 Grade C periodontitis aged between 22 and 35 years. Before the surgery, the selected quadrants were randomly allocted (by the toss of a coin) into test and control sites where the control site were treated with MWF+sham application of DL and test sites were treated with MWF+ active DL. Clinical parameters including CAL, PD, plaque index(PI), gingival index(GI), bleeding on probing (BOP) were recorded and microbiological sampling were obtained at preoperative and at 6 weeks, 3 months, 6 months postoperatively. Pain scale assessment (visual analog scale, VAS), pain medication consumption (PM), tissue edema (TE), and tissue color (TC) were evaluated one week following surgery. Microbiological analysis was done by real-time polymerase chain reaction (PCR) for detection of Porphyromonas gingivalis (P.g.), Treponema denticola (T.d.), Tannerella forsythia (T.f.), Camplyobacter rectus (C.r.), Prevotella intermedia (P.i.), Aggregatibacter actinomycetemcomitans (A.a.). Control sites were treated MWF with sham application of DL, while test sites were treated MWF with the applying of active DL (810nm±5, Picasso-AMD, USA) to the inside of the MWF. The interval between the two surgeries was 3 weeks. The modified Widman flap technique was applied.DL with a wavelength of 810±5 nm and a power of 1 watt in continuous mode was applied to the MWF at the test sites. A 400 micron diameter tip was used to remove all visible epithelium on the inside of the flap from the free gingival edge to the lower apical aspect of the flap (both labial and lingual / palatal). The tip was started using a blue articulating paper. DL irradiation performed at a 45o angle to the soft tissue flap to avoid any laser (810nm±5) contact to the root surface or the alveolar bone . DL therapy was carried out to soft tissue from the coronal to the apical aspect in parallel paths for 10seconds. When irradiation exceeded 10 seconds in time, laser (810nm) emission was be interrupted for 30 seconds. The resultant char layer was be totally removed with moist gauze prior to replacing the flaps. A second laser application with the same laser (810nm±5) was performed on all the surfaces of the flap in continuous mode at 0.1 watts. All surfaces of the flap, inner and outer, exposed bone and exposed root structures involved in the surgery were irradiated, leading to a total dosage of 4 J/cm2 per surface. The subjects were prescribed 200 mg Ibuprofen (up to 3 tablets) every 8 hours to reduce pain. The subjects were instructed not to eat solid food using the treated area and to not brush the teeth in the treated area. They were told to rinse their mouth with chlorhexidine digluconate (0.2%, CHX) twice a day for 1 min during one week after surgery The sutures were removed at first week . After 1 weeks, the subject started brushing their teeth and oral hygiene training was repeated. Oral hygiene instructions were provided at each postoperative visit.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Periodontitis, Aggressive, Diode Laser Therapy, Periodontal Diseases
    Keywords
    diode laser, aggressive periodontitis, Modified Widman Flap, microbiology

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    18 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Active Diode Laser Therapy+ Modified Widman Flap
    Arm Type
    Active Comparator
    Arm Description
    Diode laser with a wavelength of 810±5 nm and a power of 1 watt in continuous mode was applied to the Modified Widman Flap at the test sites
    Arm Title
    Sham Diode Laser Therapy+ Modified Widman Flap
    Arm Type
    Sham Comparator
    Arm Description
    Control sites were treated with MWF alone
    Intervention Type
    Device
    Intervention Name(s)
    Diode Laser
    Other Intervention Name(s)
    Modified Widman Flap (MFW)
    Intervention Description
    DL with a wavelength of 810±5 nm, a 400micron diameter, and a power of 1 watt in continuous mode was applied to the MWF at the test sites.
    Intervention Type
    Procedure
    Intervention Name(s)
    Modified Widman Flap
    Intervention Description
    Periodontal Surgery Technique
    Primary Outcome Measure Information:
    Title
    Clinical Attachment Level
    Description
    distance between the cemento-enamel junction to the deepest point of periodontal pocket
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Probing depth
    Description
    distance between the gingival margin to the deepest point of periodontal pocket
    Time Frame
    6 months
    Other Pre-specified Outcome Measures:
    Title
    Plaque index
    Description
    oral hygiene scores: 0: no plague, 3: visible plaque
    Time Frame
    6 months
    Title
    Gingival index
    Description
    gingival inflammation score 0: no bleeding, 3: severe bleeding
    Time Frame
    6 months
    Title
    Counts of bacteria
    Description
    change in bacteria levels
    Time Frame
    6 months
    Title
    Vascular analog scale
    Description
    Pain scale: 1: no pain 10: severe pain
    Time Frame
    postoperatively first week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    22 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The inclusion criteria for stage 3-grade C periodontitis patients were interdental CAL ≥ 5 mm and PD ≥ 6 mm on at least 6 teeth and at least three of these six teeth were not molars or incisors. They were under 35 years of age. These patients had at least two quadrants of maxilla with three teeth each having CAL ≥ 5 mm and PD ≥ 6 mm. Exclusion Criteria: : systemic conditions such as; diabetes mellitus, cancer, cardiovascular and respiratory diseases, current and ex-smoking habits, undergone non-surgical periodontal therapy and prescription of antibiotics or non-steroidal anti-inflammatory medication within the previous 6 months or surgical periodontal treatment within the preceding year, pregnancy, lactation, postmenopause, or immunologic disorders,
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Figen Öngöz Dede, PhD, DDS
    Organizational Affiliation
    T.C. ORDU ÜNİVERSİTESİ
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Şeyma Bozkurt Dogan, PhD, DDS
    Organizational Affiliation
    Ankara Yildirim Beyazıt University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    36070584
    Citation
    Dogan SB, Akca G. Clinical Evaluation of Diode Laser-Assisted Surgical Periodontal Therapy: A Randomized Split-Mouth Clinical Trial and Bacteriological Study. Photobiomodul Photomed Laser Surg. 2022 Sep;40(9):646-655. doi: 10.1089/photob.2022.0035. Epub 2022 Sep 7.
    Results Reference
    derived

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    Diode Laser With Periodontal Flap Surgery in Periodontitis

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