Oral health related quality of life among patients receiving non-surgical periodontal therapy by hand and ultrasonic instruments delivered by different modes: a randomized clinical trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Enrollment
- 380
- Locations
- 1
- Primary Endpoint
- Difference in Oral Impact on Daily Performance (OIDP) score between baseline (T1) and third month (T2).
Study Overview
Brief Summary
This study is a randomized clinical trial to assess the oral health related quality of life in patients undergoing non-surgical periodontal therapy by hand and ultrasonic scaler instruments which will be delivered by different modes, being carried out at Department of Periodontics, Government Dental College, Kottayam, Kerala. The selected study subjects who will give their willingness to participate, will be randomly assigned to any one of the five groups by sequentially numbered sealed opaque envelopes.
Periodontal charting will be done before the initiation of treatment along with their response to a questionnaire consisting of eight items to rate the impact of their oral health on their quality of life. The participants will be re-examined after 3 months and the same data will be recorded. Quantitative variables will be summarized into mean and standard deviation and significance of difference between the groups will be tested using one way ANOVA test. Intra-group difference at pre-treatment and post-treatment for oral health related quality of life will be compared using paired t-test.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients diagnosed with stage II and III periodontitis based on 2017 world workshop on the classification of periodontal and peri-implant diseases and conditions.
- •Presence of more than or equal to sixteen permanent teeth in the mouth with at least one permanene molar an one incisor teeth in each quadrant.
- •Subjects with good general health.
- •No periodontal treatment done in the last six months.
Exclusion Criteria
- •Antibiotics or analgesics usage three months before or its need during the study period.
- •Pregnant and lactating mothers.
- •Presence of acute periodontal infections.
- •Usage of any medications affecting neural or motor systems.
Outcomes
Primary Outcomes
Difference in Oral Impact on Daily Performance (OIDP) score between baseline (T1) and third month (T2).
Time Frame: Three months
Secondary Outcomes
- Difference in Periodontal Inflamed Surface Area (PISA) value between baseline (T1) & third month (T2).(Three months)
Investigators
Dr. Tony Kurien. J
Government Dental College, Kottayam