Periodontitis, AggressiveNCT05108727
Diode Laser With Periodontal Flap Surgery in Periodontitis
A study testing Diode Laser and Modified Widman Flap in people with Periodontitis, Aggressive and Diode Laser Therapy, run by Bulent Ecevit University.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 35 years
- Conditions the study is for
- Periodontitis, Aggressive, Diode Laser Therapy, Periodontal Diseases
- What is being tested?
- Diode Laser and Modified Widman Flap
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- : 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,
About this study
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
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
Read the 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.
- Being tested
- Diode Laser, Modified Widman Flap
- Keywords
- diode laser, aggressive periodontitis, Modified Widman Flap, microbiology
- Medical subject headings
- Aggressive Periodontitis, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diode LaserDevice
Also called Modified Widman Flap (MFW)
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.
Modified Widman FlapProcedure or surgery
Periodontal Surgery Technique
| Study group | Role | What they receive |
|---|---|---|
| Active Diode Laser Therapy+ Modified Widman Flap | Active comparator | 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 Receives: Device: Diode Laser; Procedure: Modified Widman Flap |
| Sham Diode Laser Therapy+ Modified Widman Flap | Sham comparator | Control sites were treated with MWF alone Receives: Procedure: Modified Widman Flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Attachment Level
distance between the cemento-enamel junction to the deepest point of periodontal pocket
Measured: 6 months
Secondary outcomes (1)
Probing depth
distance between the gingival margin to the deepest point of periodontal pocket
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study startJan 2013
- Primary completionFeb 2016
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Periodontitis, AggressiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyma Bozkurt Doğan, Ankara Yildirim Beyazıt University
- Investigators
- Figen Öngöz Dede, PhD, DDS, Principal investigator, Ordu UniversityŞeyma Bozkurt Dogan, PhD, DDS, Study chair, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05108727
- Sponsor's protocol ID
- 2012-21-008
- Status last verified
- Nov 2021
- First submitted
- 24 Oct 2021
- Last updated
- 5 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36070584
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05108727
- Acronym / sponsor ID
- 2012-21-008
- Keywords
- diode laser, aggressive periodontitis, Modified Widman Flap, microbiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 5 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Diode Laser Therapy+ Modified Widman Flap | Active comparator | Device: Diode Laser, Procedure: Modified Widman FlapDiode 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 |
| Sham Diode Laser Therapy+ Modified Widman Flap | Sham comparator | Procedure: Modified Widman FlapControl sites were treated with MWF alone |
Who may qualify
- Ages
- 22 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- : 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diode LaserAlso: Modified Widman Flap (MFW)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. | Device | Active Diode Laser Therapy+ Modified Widman Flap |
| Modified Widman FlapPeriodontal Surgery Technique | Procedure or surgery | Active Diode Laser Therapy+ Modified Widman Flap, Sham Diode Laser Therapy+ Modified Widman Flap |
Primary outcome
Clinical Attachment Level
Time frame: 6 months
distance between the cemento-enamel junction to the deepest point of periodontal pocket
1 secondary outcome
Probing depth
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2021.
- Derived from this study: PubMed 36070584Dogan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Figen Öngöz Dede, PhD, DDS principal investigator
Ordu University
Şeyma Bozkurt Dogan, PhD, DDS study chair
Ankara Yildirim Beyazıt University
Questions about this trial
What is this clinical trial studying?
A study testing Diode Laser and Modified Widman Flap in people with Periodontitis, Aggressive and Diode Laser Therapy, run by Bulent Ecevit University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Attachment Level (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05108727, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2021.