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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Pamukkale
-
Denizli, Pamukkale, Turkiet (Türkiye), 20160
- Pamukkale University
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Quadrant based scaling and root plannig
|
Quadrant-Based Treatment treats one quadrants at a time over four weeks
Andra namn:
|
|
Experimentell: 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
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Quality of life questionnaires
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percentage of Deep (≥ 7 mm) Probed Pockets
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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,
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
Tidsram: 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
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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Gizem Torumtay Cin, Assoc. Prof., Pamukkale University, Faculty of Dentistry, Department of Periodontology
- Huvudutredare: Emine Ece Barlay, Pamukkale University Faculty of Dentistry, Department of Periodontology
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
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
- E-60116787-020-601323
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
produkt tillverkad i och exporterad från U.S.A.
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 .