Skip to main content
. 2015 Apr 17;2015(4):CD004622. doi: 10.1002/14651858.CD004622.pub3

Wennström 2005.

Methods Study design: RCT with 2‐arm parallel design
Recruitment period: during 2002
Setting: University Dental Hospital (Sweden), private dental office (Italy)
 Number of centres: Two
 Funding Source: Industry funding
Participants Inclusion criteria: Diagnosis: Chronic periodontitis‐ with PD of > 5 mm and BOP. All patients were in good general health
Exclusion criteria: SRP over last 12 months, antibiotics from 3 months before or during study, pregnant
Age: 25 to 75
Gender: 19 F (8/11) and 22 M (12/10)
 Smokers: 20 (9/11)
 Number randomised: 42
 Number evaluated: 41 (20/21)
Interventions Comparison: FMS vs control
Test group: (FM‐UD‐test): FMS 1‐h session ultrasonic scaling with water, re‐instrumentation after 3 months in PPD > 4 mm.
Control group: (Q‐SRP‐control): QRP 4 sessions hand instrumentation ‐ 1‐week intervals (time recorded, no time restriction), re‐instrumentation after 3 months in PPD > 4 mm
 OHI before study start: yes
 Instruments used: Hand and US instruments
 Time per Q: 1 hour
 Maintenance: 1 month following completion of instrumentation (both groups)
Retreatment: at 3 months
Duration of study: 6 months
Outcomes Primary outcome: PPD (6 sites per tooth)
Secondary outcomes: CAL, BOP (6 sites per tooth). Manual probe for all measurements
Teeth: Whole‐mouth recordings (baseline, 3 and 6 months). Data split in initial moderate (PPD 5 to 6 mm) and deep pockets (PPD > 6 mm)
Pocket depth at baseline: moderate (PPD 5‐6 mm) and deep pockets (PPD > 7 mm)
Outcome time reported: 3 months used. 3 and 6 months measured.
 Other outcomes: PI, Average pain VAS score (100 mm scale)
Notes For BOP: Data supplemented by authors
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "Within each of these subgroups, a random assignment to the two treatment protocols (Fig. 1) was subsequently performed by the use of
 computer‐generated tables".
Allocation concealment (selection bias) Low risk "Allocation concealment was secured by (i) having a person not otherwise involved in the study performing the randomisation
 and (ii) providing the centres (the dental hygienists) with sealed envelopes containing only the assignment for the individual subject"
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: 42 enrolled, 41 randomised, and 41 present at 6 months.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk "One examiner (a periodontist), who was masked with respect to the treatment assignments, performed all examinations".
Selective reporting (reporting bias) Low risk Data reported on all primary and secondary outcomes.
Other bias Low risk Baseline balance good for pocket depth and smoking. No apparent other biases.