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Comparing three non-surgical treatments for gum disease

Management of periodontitis by three different approaches to non-surgical periodontal debridement – a comparative clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13350022
Enrollment
45
Registered
2025-05-28
Start date
2021-01-25
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontitis Oral Health

Interventions

As guided by the previous literature, preliminary sample size estimation revealed that the required number of patients is 36 (12 patients in one treatment group) at partial eta squared = 0.25, alpha =

Sponsors

University of Peradeniya
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged =35 years diagnosed with generalized stage II and III periodontitis, with at least three (03) treatable quadrants in the mouth requiring RSD, with a minimum of four teeth in any quadrant with deep pockets 2. Only those patients who consented to undergo treatment according to a random assignment into any of the three methods of periodontal debridement were included.

Exclusion criteria

Exclusion criteria: 1. Those who had underlying systemic conditions (uncontrolled diabetes mellitus, leukemia/haematological disorders, pregnancy, and medication-induced gingival overgrowth) 2. Those who were current or previous smokers 3. The patients who had undergone periodontal treatment within the preceding 6 months 4. Those who were on systemic antibiotics within the last 3 months 5. Those who had used oral chlorhexidine preparations or other disinfectants within the previous month

Design outcomes

Primary

MeasureTime frame
Bleeding scores and probing pocket depths were recorded at baseline and post-non-surgical periodontal therapy after 8 weeks. The parameters were recorded in six-point pocket charts. Full mouth bleeding score was also obtained dichotomously, as present or absent upon probing and calculated as a percentage. Probing pocket depths were measured in millimetres using a William’s periodontal probe at six sites of each tooth. Probing depths of 4 mm or greater with bleeding on probing were classified as deep pockets needing root surface debridement. This is in accordance with the current recommendations for achieving endpoints of non-surgical periodontal therapy. The percentage of deep pocket distribution was obtained by dividing the total number of deep pockets (=4 mm with bleeding) by the total number of tooth sites in the mouth.

Secondary

MeasureTime frame
Plaque Scores (%) at baseline and post-treatment after 8 weeks. Plaque (disclosed with disclosing solution) was dichotomously scored as present or absent in a plaque chart, and the full mouth plaque score was obtained as a percentage.

Countries

Sri Lanka

Contacts

Public ContactUthpala Gunasekara
uthpalagunasekara@gmail.com+94(0)711701051

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026