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A Comparison of Single-Stage Full-Mouth Disinfection With Quadrant-Based Scaling and Root Planing in Patients With Uncontrolled Type 2 Diabetes and Severe Periodontitis: An Assessment of Its Impact on Quality of Life

19 maja 2026 zaktualizowane przez: Emine Ece Barlay, Pamukkale University
This study evaluated the effects of a single-stage full mouth disinfection (FMD) protocol versus a quadrant-based tooth surface cleaning and root planing (Q-SRP) protocol on changes in clinical periodontal parameters over a 3-month period, as well as on the social, psychological and functional well-being of patients with poorly controlled type 2 diabetes and severe periodontitis.

Przegląd badań

Szczegółowy opis

In this study, Q-SRP was administered to one group of patients with uncontrolled diabetes and severe periodontitis, whilst the TAD protocol was implemented in the other group. All clinical procedures were carried out in accordance with standard protocols. Post-treatment assessments were carried out at the 1-month and 3-month follow-up periods; all clinical periodontal measurements recorded at baseline, along with the OHIP-14 and OIDP questionnaires, were repeated in the same manner. This enabled a comparative analysis of the efficacy of the treatment methods applied and the clinical changes over time.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

82

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

    • Pamukkale
      • Denizli, Pamukkale, Turcja (Türkiye), 20160
        • Pamukkale University

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

Inclusion Criteria:

  • Individuals with poorly controlled diabetes and HbA1c levels between 7% and 9%
  • At least 15 natural teeth and, from a periodontal perspective: probing pocket depth (PPD) ≥ 6 mm, clinical attachment loss (CAL) ≥ 5 mm, radiographic bone loss extending to the middle or apical third of the root, and periodontitis-related tooth loss of ≤ 4 in different quadrants

Exclusion Criteria:

  • Individuals who were pregnant or breastfeeding
  • Patients with a history of acute or chronic infection within the past 6 months
  • Patients who had undergone periodontal treatment within the past 6 months
  • Patients receiving systemic antibiotic therapy during the same period
  • Patients using non-steroidal anti-inflammatory drugs, phenytoin, calcium channel blockers or cyclosporine
  • Patients undergoing hormone therapy
  • Individuals who had used antibiotics or anti-inflammatory drugs regularly during the 3-month period following the start of the study
  • İndividuals with medical or psychological conditions that could affect the accurate understanding and completion of the questionnaires
  • Smokers

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie podtrzymujące
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: Quadrant based scaling and root plannig
Quadrant-Based Treatment treats one quadrants at a time over four weeks
Inne nazwy:
  • Q-SRP
Eksperymentalny: Full mouth disinfection
Full Mouth Disinfection involves scaling and root planing all teeth within 24 hours, often paired with intensive antiseptics to prevent re-infection from remaining pockets
Inne nazwy:
  • FMD

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Quality of life questionnaires
Ramy czasowe: Before treatment, 1 and 3 months after treatment
The impact of periodontal treatments on patients' quality of life was investigated by administering the OHIP-14 and OIDP questionnaires at baseline, one month post-treatment, and three months post-treatment. Responses obtained from participants via the OHIP-14 questionnaire were assessed using a five-point Likert scale for each item. The scale was scored as follows: 0 (never), 1 (rarely), 2 (occasionally), 3 (often) and 4 (very often). The total oral health-related quality of life score for each individual was calculated by summing the scores given for each question.
Before treatment, 1 and 3 months after treatment

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Percentage of Deep (≥ 7 mm) Probed Pockets
Ramy czasowe: Before treatment, month after treatment and 3 months after treatment

During measurements taken using a Williams periodontal probe (Hu Friedy, Chicago, Illinois, USA), the probe was positioned parallel to the long axis of the teeth without applying pressure, and the distance from the gingival margin to the base of the periodontal pocket was measured and recorded. The percentage of pocket depths of 7 mm or more, measured from the six regions of each tooth (mesiobuccal, buccal, distobuccal, mesiolingual, lingual and distolingual), was calculated relative to the total number of tooth surfaces measured in the mouth. The percentage of all pocket depths of 7 mm or more in the individual's mouth was calculated using the following formula.

% ≥ 7 mm PD = Total of pocket depths of 7 mm or more × 100 / Total number of teeth × 6

Before treatment, month after treatment and 3 months after treatment
Percentage of Pockets Detected at Medium Depth (4-6 mm)
Ramy czasowe: Before treatment, month after treatment and 3 months after treatment

During measurements taken using a Williams periodontal probe (Hu Friedy, Chicago, Illinois, USA), the probe was positioned parallel to the long axis of the teeth without applying pressure, and the distance from the gingival margin to the base of the periodontal pocket was measured and recorded. The percentage of pocket depths within the 4-6 mm range, measured from six regions of each tooth (mesiobuccal, buccal, distobuccal, mesiolingual, lingual and distolingual), was calculated relative to the total number of tooth surfaces measured in the mouth. The percentage of pocket depths within the 4-6 mm range for the entire mouth was calculated using the following formula.

%4-6 mm PD = (Total of 4-6 mm pocket depths × 100) / (Total number of teeth × 6)

Before treatment, month after treatment and 3 months after treatment
Clinical Attachment Level
Ramy czasowe: Before treatment, month after treatment and 3 months after treatment

The distance from the enamel-cementum junction to the sulcus/pocket floor was measured in millimetres on six surfaces of the tooth-mesiobuccal, buccal, distobuccal, mesiolingual, lingual and distolingual-using a Williams periodontal probe (Williams periodontal probe, Hu Friedy, Chicago, IL, USA). The average CAL value for the entire mouth was calculated using the following formula:

CAL = Sum of clinical attachment levels / Number of existing teeth × 6

Before treatment, month after treatment and 3 months after treatment
Probed Pocket Depth
Ramy czasowe: Before treatment, month after treatment and 3 months after treatment

Pocket depth was measured in six regions: mesiobuccal, buccal, distobuccal, mesiolingual, lingual and distolingual. A Williams periodontal probe was used for the measurements (Hu Friedy, Chicago, Illinois, USA).

During the measurements, the periodontal probe was positioned parallel to the long axis of the teeth without applying pressure, and the distance from the gingival margin to the base of the periodontal pocket was measured and recorded. The following formula was used to determine the average PD for the individual's entire mouth.

PD = Sum of probed pocket depths / Number of existing teeth × 6

Before treatment, month after treatment and 3 months after treatment
Bleeding on Probing
Ramy czasowe: Before treatment, month after treatment and 3 months after treatment

When the periodontal probe was gently moved along the gingival sulcus, a score of (+) was assigned if bleeding occurred, and (-) if no bleeding occurred. The final score was calculated as a percentage (%).

Bleeding Score (%) = Number of teeth with bleeding × 100 / Total number of teeth

Before treatment, month after treatment and 3 months after treatment
Plaque Index
Ramy czasowe: Before treatment, month after treatment and 3 months after treatment

The Silness-Löe plaque index (PI) was used to measure the degree of plaque formation and accumulation in the mouth. According to this index:

0 = No bacterial plaque in the gingival region,

  1. = The presence of plaque that is not visible to the naked eye at the free gingival margin but can be detected by moving the probe through the gingival sulcus,
  2. = The presence of moderate plaque within the gingival pocket and on the tooth surface adjacent to the gingival margin,
  3. = The presence of a visible amount of dense, soft deposit within the gingival pocket and on the tooth surface adjacent to the gingival margin.

The individual's PI score was calculated using the following formula after summing the PI scores obtained from the mesiobuccal, buccal, distobuccal and lingual surfaces of each tooth.

PI = Total of PI scores for all teeth / Number of teeth present × 4

Before treatment, month after treatment and 3 months after treatment
Gingival Index
Ramy czasowe: Before treatment, month after treatment and 3 months after treatment

The Löe-Silness gingival index (GI) was used to diagnose gingival inflammation. According to this classification:

0=Healthy gums

  1. = Mild inflammation: Mild discolouration and mild swelling present, but no bleeding on probing
  2. = Moderate inflammation: Redness, swelling, glossiness and bleeding on probing
  3. = Severe inflammation: Marked redness and swelling. Ulcerations and a tendency towards spontaneous bleeding are present.

The individual's GI score was calculated using the following formula after summing the GI scores obtained from the mesiobuccal, buccal, distobuccal and lingual surfaces of each tooth.

GI = Total of GI scores for all teeth / Number of existing teeth × 4

Before treatment, month after treatment and 3 months after treatment

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Śledczy

  • Dyrektor Studium: Gizem Torumtay Cin, Assoc. Prof., Pamukkale University, Faculty of Dentistry, Department of Periodontology
  • Główny śledczy: Emine Ece Barlay, Pamukkale University Faculty of Dentistry, Department of Periodontology

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

13 listopada 2024

Zakończenie podstawowe (Rzeczywisty)

3 marca 2026

Ukończenie studiów (Rzeczywisty)

3 marca 2026

Daty rejestracji na studia

Pierwszy przesłany

12 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

19 maja 2026

Pierwszy wysłany (Rzeczywisty)

20 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

20 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

19 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • E-60116787-020-601323

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Ciężkie zapalenie przyzębia

Badania kliniczne na Quadrant based scaling and root planning

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