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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 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

82

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Quadrant based scaling and root plannig
Quadrant-Based Treatment treats one quadrants at a time over four weeks
Altri nomi:
  • Q-SRP
Sperimentale: 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
Altri nomi:
  • FMD

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Quality of life questionnaires
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Deep (≥ 7 mm) Probed Pockets
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Direttore dello studio: Gizem Torumtay Cin, Assoc. Prof., Pamukkale University, Faculty of Dentistry, Department of Periodontology
  • Investigatore principale: Emine Ece Barlay, Pamukkale University Faculty of Dentistry, Department of Periodontology

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

13 novembre 2024

Completamento primario (Effettivo)

3 marzo 2026

Completamento dello studio (Effettivo)

3 marzo 2026

Date di iscrizione allo studio

Primo inviato

12 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

19 maggio 2026

Primo Inserito (Effettivo)

20 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

20 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

19 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • E-60116787-020-601323

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Prove cliniche su Quadrant based scaling and root planning

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