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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. května 2026 aktualizováno: 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.

Přehled studie

Detailní popis

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 studie

Intervenční

Zápis (Aktuální)

82

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Podpůrná péče
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: Quadrant based scaling and root plannig
Quadrant-Based Treatment treats one quadrants at a time over four weeks
Ostatní jména:
  • Q-SRP
Experimentální: 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
Ostatní jména:
  • FMD

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Quality of life questionnaires
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Percentage of Deep (≥ 7 mm) Probed Pockets
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Ředitel studie: Gizem Torumtay Cin, Assoc. Prof., Pamukkale University, Faculty of Dentistry, Department of Periodontology
  • Vrchní vyšetřovatel: Emine Ece Barlay, Pamukkale University Faculty of Dentistry, Department of Periodontology

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

13. listopadu 2024

Primární dokončení (Aktuální)

3. března 2026

Dokončení studie (Aktuální)

3. března 2026

Termíny zápisu do studia

První předloženo

12. května 2026

První předloženo, které splnilo kritéria kontroly kvality

19. května 2026

První zveřejněno (Aktuální)

20. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

20. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

19. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • E-60116787-020-601323

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

produkt vyrobený a vyvážený z USA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Quadrant based scaling and root planning

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