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NCT Number: NCT07598071

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pamukkale University

Denizli, Pamukkale, 20160, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quadrant based scaling and root planning

Procedure

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

Other names: Q-SRP

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

Other names: FMD

Primary outcomes

  1. Quality of life questionnaires

    Time frame: 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 outcomes

  1. Percentage of Deep (≥ 7 mm) Probed Pockets

    Time frame: 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

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

    Time frame: 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)

  3. Clinical Attachment Level

    Time frame: 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

  4. Probed Pocket Depth

    Time frame: 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

  5. Bleeding on Probing

    Time frame: 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

  6. Plaque Index

    Time frame: 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 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

  7. Gingival Index

    Time frame: 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

    • = 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

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 20, 2026
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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