- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07822269
Dental Loupe Versus Dental Operating Microscope for Non-Surgical Periodontal Treatment
Comparison of the Effectiveness of Dental Loupe and Dental Operating Microscope in Non-Surgical Periodontal Treatment
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Tuğçe Paksoy, Associate Professor
- Telefonnummer: +905534490452
- E-post: tugceakap86@hotmail.com
Studieorter
-
-
-
Ankara, Turkiet (Türkiye)
- Har inte rekryterat ännu
- Sağlık Bilimleri Üniversitesi Gülhane Diş Hekimliği Fakültesi
-
Kontakt:
- Seval Ceylan Şen, Assistant Professor
- Telefonnummer: +905333161232
- E-post: dt.sceylan@hotmail.com
-
Kontakt:
- Özlem Saraç Atagün, Assistant Professor
- Telefonnummer: +905055096482
- E-post: ozlemsarac2806@hotmail.com
-
Underutredare:
- Gülbahar Ustaoğlu, Associate Professor
-
Kırklareli, Turkiet (Türkiye)
- Har inte rekryterat ännu
- Kırklareli Üniversitesi Tıp Fakültesi Tıbbi Mikrobiyoloji Anabilim Dalı
-
Kontakt:
- Mehmet Demirci, Professor
- Telefonnummer: 05337106295
- E-post: demircimehmet@hotmail.com
-
-
Üsküdar
-
Istanbul, Üsküdar, Turkiet (Türkiye)
- Rekrytering
- Sağlık Bilimleri Üniversitesi Hamidiye Diş Hekimliği Fakültesi
-
Kontakt:
- Tuğçe Paksoy, Associate Professor
- Telefonnummer: +905534490452
- E-post: tugceakap86@hotmai.com
-
Kontakt:
- Alima Budakçı, PHd candidate
- Telefonnummer: +905319841597
- E-post: alima-97@hotmail.com
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Dental Loupe
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.
|
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.
|
|
Experimentell: Dental Microscope
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.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Total microbial load
Tidsram: 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. |
At enrollment. and 1 month control visit
|
|
Probing Pocket Depth
Tidsram: 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.
|
At enrollment, 1 and 3 months control visits
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Gingival Index
Tidsram: 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.
|
At enrollment, 1 and 3 months control visits
|
|
Papillary Bleeding Index
Tidsram: 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.
|
At enrollment, 1 and 3 months control visits
|
|
Plaque Index (PI/ Turesky Gilmore Glickman modification of the Quingley Hein plaque index)
Tidsram: 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. |
At enrollment, 1 and 3 months control visits
|
|
Gingival Bleeding Index (Ainamo & Bay)
Tidsram: 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.
|
At enrollment, 1 and 3 month control visits
|
|
Clinical attachment loss
Tidsram: 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.
|
At enrollment, 1 and 3 months control visits
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 25-25
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .