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
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
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
NCT ID
NCT05108727
First Posted
October 24, 2021
Last Updated
November 3, 2021
Sponsor
Bulent Ecevit University
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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