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

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.

Study Overview

• Status: Completed
• Conditions: Severe Periodontitis; Uncontrolled Type 2 Diabetes Mellitus
• Intervention / Treatment: Procedure: Quadrant based scaling and root planning; Procedure: full mouth disinfeciton

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.

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Quadrant based scaling and root plannig	Procedure: Quadrant based scaling and root planning; Quadrant-Based Treatment treats one quadrants at a time over four weeks; Other Names: Q-SRP
Experimental: Full mouth disinfection	Procedure: full 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; Other Names: FMD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life questionnaires	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Deep (≥ 7 mm) Probed Pockets	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)	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	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	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	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	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 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,; = The presence of moderate plaque within the gingival pocket and on the tooth surface adjacent to the gingival margin,; = 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	The Löe-Silness gingival index (GI) was used to diagnose gingival inflammation. According to this classification: 0=Healthy gums; = Mild inflammation: Mild discolouration and mild swelling present, but no bleeding on probing; = Moderate inflammation: Redness, swelling, glossiness and bleeding on probing; = 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

Collaborators and Investigators

• Sponsor: Pamukkale University
• Investigators: Study Director: Gizem Torumtay Cin, Assoc. Prof., Pamukkale University, Faculty of Dentistry, Department of Periodontology; Principal Investigator: Emine Ece Barlay, Pamukkale University Faculty of Dentistry, Department of Periodontology

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2024
• Primary Completion (Actual): March 3, 2026
• Study Completion (Actual): March 3, 2026

Study Registration Dates

• First Submitted: May 12, 2026
• First Submitted That Met QC Criteria: May 19, 2026
• First Posted (Actual): May 20, 2026

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: full mouth disinfection; quadrant based scaling and root plannig
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontitis
• Other Study ID Numbers: E-60116787-020-601323

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No