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

NCT07598071 | Completed

• 1 other identifier: E-60116787-020-601323
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Uncontrolled Type 2 Diabetes Mellitus; Severe Periodontitis

Keywords

full mouth disinfection; quadrant based scaling and root plannig

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Percentage of Deep (≥ 7 mm) Probed Pockets

  Before treatment, month after treatment and 3 months after treatment

• Percentage of Pockets Detected at Medium Depth (4-6 mm)

  Before treatment, month after treatment and 3 months after treatment

• Clinical Attachment Level

  Before treatment, month after treatment and 3 months after treatment

• Probed Pocket Depth

  Before treatment, month after treatment and 3 months after treatment

• Bleeding on Probing

  Before treatment, month after treatment and 3 months after treatment

Study Arms (2)

Quadrant based scaling and root plannig

ACTIVE COMPARATOR

Quadrant based scaling and root plannig

Procedure: Quadrant based scaling and root planning

Full mouth disinfection

EXPERIMENTAL

Full mouth disinfection

Procedure: full mouth disinfeciton

Interventions

Quadrant based scaling and root planning PROCEDURE

Quadrant-Based Treatment treats one quadrants at a time over four weeks

Also known as: Q-SRP

Quadrant based scaling and root plannig

full mouth disinfeciton PROCEDURE

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

Also known as: FMD

Full mouth disinfection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University

Denizli, Pamukkale, 20160, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Gizem Torumtay Cin, Assoc. Prof.

  Pamukkale University, Faculty of Dentistry, Department of Periodontology

  STUDY DIRECTOR

• Emine Ece Barlay

  Pamukkale University Faculty of Dentistry, Department of Periodontology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 20, 2026
• Study Start: November 13, 2024
• Primary Completion: March 3, 2026
• Study Completion: March 3, 2026
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)