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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 мая 2026 г. обновлено: 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.

Обзор исследования

Подробное описание

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.

Тип исследования

Интервенционный

Регистрация (Действительный)

82

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Нет

Описание

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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Поддерживающая терапия
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Двойной

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Активный компаратор: Quadrant based scaling and root plannig
Quadrant-Based Treatment treats one quadrants at a time over four weeks
Другие имена:
  • Q-SRP
Экспериментальный: 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
Другие имена:
  • Ящур

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Quality of life questionnaires
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Percentage of Deep (≥ 7 mm) Probed Pockets
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Следователи

  • Директор по исследованиям: Gizem Torumtay Cin, Assoc. Prof., Pamukkale University, Faculty of Dentistry, Department of Periodontology
  • Главный следователь: Emine Ece Barlay, Pamukkale University Faculty of Dentistry, Department of Periodontology

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

13 ноября 2024 г.

Первичное завершение (Действительный)

3 марта 2026 г.

Завершение исследования (Действительный)

3 марта 2026 г.

Даты регистрации исследования

Первый отправленный

12 мая 2026 г.

Впервые представлено, что соответствует критериям контроля качества

19 мая 2026 г.

Первый опубликованный (Действительный)

20 мая 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

20 мая 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

19 мая 2026 г.

Последняя проверка

1 мая 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Другие идентификационные номера исследования

  • E-60116787-020-601323

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

продукт, произведенный в США и экспортированный из США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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