NCT05108727

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 5, 2021

Completed
Last Updated

November 5, 2021

Status Verified

November 1, 2021

Enrollment Period

3.1 years

First QC Date

October 24, 2021

Last Update Submit

November 3, 2021

Conditions

Periodontitis, AggressiveDiode Laser TherapyPeriodontal Diseases

Keywords

diode laseraggressive periodontitisModified Widman Flapmicrobiology

Outcome Measures

Primary Outcomes (1)

  • Clinical Attachment Level

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

    6 months

Secondary Outcomes (1)

  • Probing depth

    6 months

Other Outcomes (4)

  • Plaque index

    6 months

  • Gingival index

    6 months

  • Counts of bacteria

    6 months

  • +1 more other outcomes

Study Arms (2)

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

Device: Diode LaserProcedure: Modified Widman Flap

Sham Diode Laser Therapy+ Modified Widman Flap

SHAM COMPARATOR

Control sites were treated with MWF alone

Procedure: Modified Widman Flap

Interventions

Diode LaserDEVICE

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.

Also known as: Modified Widman Flap (MFW)
Active Diode Laser Therapy+ Modified Widman Flap
Modified Widman FlapPROCEDURE

Periodontal Surgery Technique

Active Diode Laser Therapy+ Modified Widman FlapSham Diode Laser Therapy+ Modified Widman Flap

Eligibility Criteria

Age22 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • : 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 36070584DERIVED

MeSH Terms

Conditions

Aggressive PeriodontitisPeriodontal Diseases

Interventions

Lasers, Semiconductor

Condition Hierarchy (Ancestors)

PeriodontitisMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Officials

  • Figen Öngöz Dede, PhD, DDS

    Ordu University

    PRINCIPAL INVESTIGATOR

  • Şeyma Bozkurt Dogan, PhD, DDS

    Ankara Yildirim Beyazıt University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 24, 2021

First Posted

November 5, 2021

Study Start

January 1, 2013

Primary Completion

February 1, 2016

Study Completion

March 1, 2020

Last Updated

November 5, 2021

Record last verified: 2021-11