NCT07822269

Brief Summary

Periodontitis is a multifactorial, non-infectious disease that can lead to tooth loss if left untreated. Advanced stages of periodontitis can affect chewing ability, nutritional status, and quality of life. Calculus removal, root planing, and mechanical removal of plaque should be considered a fundamental part of initial periodontal treatment. Furthermore, patients who undergo calculus removal and root planing followed by regular maintenance programs experience less tooth loss and clinical attachment loss. Calculus removal and root planing are integral parts of non-surgical periodontal treatment to remove bacterial plaque and calculus from diseased root surfaces. The use of magnification systems to increase the field of view in both surgical and non-surgical procedures dates back to the 1860s with the first use of surgical microscopes. Magnification systems were first used in dentistry in the first half of the 20th century. In 1978, Apotheker and Jako developed the first surgical microscope for use in dentistry. The use of magnifying loupes as visual aids by dentists has become increasingly popular over the years, with continuous improvements in design and effectiveness. A 2019 survey among dentists indicated that magnifying lenses are one of the significant technological advancements in this profession. Periodontal endoscopy is also one of the approaches clinicians use to improve visibility. Dental magnification systems are known to increase effectiveness, especially in interproximal areas where access and visibility are limited. Clinical studies have compared root surface planing procedures performed with periodontal endoscopy with traditional root surface planing. The results of the studies showed a significant difference in clinical outcomes in patients treated with periodontal endoscopy compared to those treated with traditional methods. The aim of this study is to analyze the clinical and microbiological benefits of image magnification systems (dental loupe and dental microscope) in scaling and root surface planing in the treatment of patients with periodontitis.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
13mo left

Started Aug 2026

Geographic Reach
1 country

3 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress14%
Aug 2026Nov 2027

Study Start

First participant enrolled

August 1, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 10, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 16, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

September 21, 2026

Status Verified

September 1, 2026

Enrollment Period

1 year

First QC Date

September 10, 2026

Last Update Submit

September 16, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Total microbial load

    To determine the amount of microorganisms, plaque samples taken from each patient will be stored in Eppendorf tubes at -80°C with sterile distilled water until microbial analysis is performed. Plaque samples stored at -80°C in Eppendorf tubes will be transported to the laboratories where microbiological examination will be performed using personal vehicles in dry ice thermal storage bags. DNA isolation from all suture samples will be performed using the High Pure PCR Template according to the manufacturer's instructions. The DNA will be stored at 80°C until the process is complete. The 16S rRNA gene will be detected by qPCR and the total bacterial count will be determined. Real-time PCR procedures will be performed on a LightCycler 480 II system using the Fast Start Essential DNA Green Master Mix Kit according to the manufacturer's instructions.

    At enrollment. and 1 month control visit

  • Probing Pocket Depth

    Probing pocket depth, or probing depth, is a numerical value obtained by measuring the distance between the gingival margin and the gingival sulcus/pocket floor using a standard periodontal probe with a tip approximately 0.4-0.5 mm in diameter, and rounding the measurement to the nearest millimeter.

    At enrollment, 1 and 3 months control visits

Secondary Outcomes (5)

  • Gingival Index

    At enrollment, 1 and 3 months control visits

  • Papillary Bleeding Index

    At enrollment, 1 and 3 months control visits

  • Plaque Index (PI/ Turesky Gilmore Glickman modification of the Quingley Hein plaque index)

    At enrollment, 1 and 3 months control visits

  • Gingival Bleeding Index (Ainamo & Bay)

    At enrollment, 1 and 3 month control visits

  • Clinical attachment loss

    At enrollment, 1 and 3 months control visits

Study Arms (2)

Dental Loupe

EXPERIMENTAL

A split-mouth study design was planned for the same patient. The patient's right or left upper or lower jaw would be treated with a dental loupe which determined by a coin toss. Patients diagnosed with periodontitis (Stage 3-Grade A) in the periodontology clinic and undergoing routine non-surgical periodontal treatment would be included in the study if they voluntarily agreed to participate.

Device: Mechanical debridement and dental plaque sample collection with dental loupe

Dental Microscope

EXPERIMENTAL

A split-mouth study design was planned for the same patient. The patient's right or left upper or lower jaw would be treated with a dental microscope which determined by a coin toss. Patients diagnosed with periodontitis (Stage 3-Grade A) in the periodontology clinic and undergoing routine non-surgical periodontal treatment would be included in the study if they voluntarily agreed to participate.

Device: Mechanical debridement and dental plaque sample collection with dental microscope

Interventions

After clinical measurements are taken from Stage 3 Grade A periodontitis patients presenting to the periodontology clinic, a coin toss determines which area will undergo mechanical debridement under dental loupe magnification and which area under dental microscope magnification. Before starting the procedure, a plaque sample will be collected from the deepest pathological pockets in the relevant area for later microbiological examination. Following supragingival and subgingival debridement under local anesthesia using Gracey curettes and an ultrasonic scaler, patients will be placed in a follow-up period.

Dental Microscope

After clinical measurements are taken from Stage 3 Grade A periodontitis patients presenting to the periodontology clinic, a coin toss determines which area will undergo mechanical debridement under dental loupe magnification and which area under dental microscope magnification. Before starting the procedure, a plaque sample will be collected from the deepest pathological pockets in the relevant area for later microbiological examination. Following supragingival and subgingival debridement under local anesthesia using Gracey curettes and an ultrasonic scaler, patients will be placed in a follow-up period.

Dental Loupe

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being over 18 years of age
  • Being systemically healthy
  • Having at least 20 permanent teeth in both upper and lower jaws
  • Having periodontitis
  • Having the mental capacity to understand the research objectives and methods to be applied as explained in writing and orally
  • Being convinced that the volunteer will be suitable and cooperative with the physician-patient before, during and after the procedure
  • Not having any physical or psychological condition that would prevent mechanical debridement
  • Not being a bacterial or viral carrier

You may not qualify if:

  • Patients under 18 years of age
  • Patients who are periodontally healthy
  • Smoking more than 10 cigarettes a day
  • Having received periodontal treatment within the last year
  • Having used antibiotics within the last 3 months
  • Being pregnant or breastfeeding
  • Those with diabetes, chronic kidney failure, cancer, bleeding disorders, connective tissue diseases, and similar chronic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Sağlık Bilimleri Üniversitesi Gülhane Diş Hekimliği Fakültesi

Ankara, Turkey (Türkiye)

NOT YET RECRUITING

Kırklareli Üniversitesi Tıp Fakültesi Tıbbi Mikrobiyoloji Anabilim Dalı

Kırklareli, Turkey (Türkiye)

NOT YET RECRUITING

Sağlık Bilimleri Üniversitesi Hamidiye Diş Hekimliği Fakültesi

Istanbul, Üsküdar, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

PeriodontitisPeriodontal DiseasesPeriodontal Pocket

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Central Study Contacts

Tuğçe Paksoy, Associate Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 10, 2026

First Posted

September 16, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

September 21, 2026

Record last verified: 2026-09

Locations