Severe Periodontitis, Uncontrolled Type 2 Diabetes Mellitus
Conditions
Keywords
full mouth disinfection, quadrant based scaling and root plannig
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREQuadrant based scaling and root planning
Quadrant-Based Treatment treats one quadrants at a time over four weeks
PROCEDUREfull mouth disinfeciton
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
Sponsors
Pamukkale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life questionnaires | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Deep (≥ 7 mm) Probed Pockets | 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 |
| Percentage of Pockets Detected at Medium Depth (4-6 mm) | 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) |
| Clinical Attachment Level | 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 |
| Probed Pocket Depth | 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 |
| Bleeding on Probing | 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 |
| Plaque Index | 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 |
| Gingival Index | 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 |
Countries
Turkey (Türkiye)
Contacts
STUDY_DIRECTORGizem Torumtay Cin, Assoc. Prof.
Pamukkale University, Faculty of Dentistry, Department of Periodontology
PRINCIPAL_INVESTIGATOREmine Ece Barlay
Pamukkale University Faculty of Dentistry, Department of Periodontology
Outcome results
None listed