Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07822269

Dental Loupe Versus Dental Operating Microscope for Non-Surgical Periodontal Treatment

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sağlık Bilimleri Üniversitesi Hamidiye Diş Hekimliği Fakültesi, Istanbul, Üsküdar, Turkey (Türkiye)

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Mechanical debridement and dental plaque sample collection with dental loupe

Procedure

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.

Mechanical debridement and dental plaque sample collection with dental microscope

Procedure

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.

Primary outcomes

  1. Total microbial load

    Time frame: At enrollment. and 1 month control visit

    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.

  2. Probing Pocket Depth

    Time frame: At enrollment, 1 and 3 months control visits

    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.

Secondary outcomes

  1. Gingival Index

    Time frame: At enrollment, 1 and 3 months control visits

    This index was developed by Löe and Silness in 1963 and modified by various researchers in 1967. The system evaluates bleeding, the most fundamental sign of inflammation. The mesial, distal, vestibular, and lingual gingiva of the teeth are assessed. These values are then summed and divided by four to calculate the gingival index. Dividing the sum of these values by the number of teeth yields the individual score.

    0 Healthy gingiva, no inflammation.

    • Mild inflammation, discoloration, and slight swelling in the gingiva; no bleeding on probing.
    • Moderate inflammation, redness, and swelling in the gingiva; bleeding on probing.
    • Severe inflammation, redness, and swelling in the gingiva; spontaneous bleeding occurs.
  2. Papillary Bleeding Index

    Time frame: At enrollment, 1 and 3 months control visits

    Probing is used to evaluate bleeding in the gingival papillae. Probing is performed on all four half-jaws. However, to ensure the evaluation reflects inflammation of all papillae and to facilitate the procedure, evaluation is performed on the papillae on the oral surfaces of the upper right and lower left jaws, and on the facial surfaces of the teeth in the upper left and lower right jaws. The values obtained are then divided by the total number of papillae to find the average papillary bleeding index value. This index is quite important for patient motivation. Patients who see bleeding in their gums can easily identify the diseased area in their mouth and develop positive behaviors in applying the oral care procedures they have been taught.

    Papillary Bleeding Index Values 0 No bleeding.

    • Slight bleeding 20 seconds after probing.
    • Linear bleeding in the papillary area after probing.
    • Bleeding filling the interdental space after probing.
    • Excessive bleeding overflowing from
  3. Plaque Index (PI/ Turesky Gilmore Glickman modification of the Quingley Hein plaque index)

    Time frame: At enrollment, 1 and 3 months control visits

    The amount of plaque on facial and lingual surfaces is investigated using a plaque-staining agent. The total score is divided by the number of surfaces examined, and an index score is determined for the individual.

    The plaque-staining agent (Tri Plaque ID Gel™, GC Dental, USA) is applied to all tooth surfaces using a fine-tipped brush.

    Areas stained pink, purple, or blue on the tooth surfaces are scored from 0 to 5 (Score 0: no plaque, 1: independent plaque islands at the gingival margins, 2: thin bands of plaque at the gingival margins, 3: plaque covering no more than 1/3 of the tooth surface, 4: plaque covering no more than 2/3 of the tooth surface, 5: plaque covering more than 2/3 of the tooth surface). The entire mouth is divided into 6 different areas, and the average TQHPI values of the participants are calculated by taking the mathematical ratio of the values obtained from the mesial, distal, lingual, and vestibular surfaces of the specific teeth in each sextant.

  4. Gingival Bleeding Index (Ainamo & Bay)

    Time frame: At enrollment, 1 and 3 month control visits

    This index assesses bleeding by gently probing within the gingival pocket. The presence or absence of bleeding in the gingiva is evaluated based on the probing results. A positive result is given if bleeding occurs within 10-15 seconds after probing the mesial, distal, vestibular, and lingual gingival areas of all teeth. The ratio of the bleeding area to the examined area is expressed as a percentage.

  5. Clinical attachment loss

    Time frame: At enrollment, 1 and 3 months control visits

    This value is obtained by measuring the distance between the pocket base and the enamel-cementum junction using a standard periodontal probe with a diameter of 0.4-0.5 mm and rounding the measurement to the nearest millimeter value.

Study contacts

Contact information is provided by the study sponsor or research team.

Tuğçe Paksoy, Associate Professor

CONTACT

[email protected]

+905534490452

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Registry information

Official study title

Comparison of the Effectiveness of Dental Loupe and Dental Operating Microscope in Non-Surgical Periodontal Treatment

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 16, 2026
Registry last updated
Sep 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.