Skip to main content
. 2022 Jun 28;2022(6):CD004622. doi: 10.1002/14651858.CD004622.pub4

Babaloo 2018.

Study characteristics
Methods Study design: RCT with 2‐arm parallel design
Recruitment period: unclear
Setting: University Dental Hospital, Iran
Number of centres: 1
Funding source: none
Participants Inclusion criteria: diagnosis: chronic periodontitis with ≥ 12 teeth
Exclusion criteria: systemic disease or on antibiotics from 2 months before or during study
Age: 25–70 years (mean: FMD: 43 (SD 12.47) years; control: 47.7 (SD 9.4))*
Sex: 19 F (FMD: 11; control: 8) and 21 M (FMD: 9; control 12)*
Smokers: unknown
Number randomised: 40 (20 per group)*
Number evaluated: 40 (20 per group)* (implied but not explicitly stated)
Interventions Comparison: FMD vs control
FMD group: US instrumentation in 2 sessions within 24 hours, subgingival: CHX 0.2%; tongue brushing: CHX 0.2%; rinse: CHX 0.2%
Control group: (Q‐SRP) QRP 4 sessions – 2‐weekly intervals, type of instruments unknown
OHI before study start: unknown
Instruments used: US instruments, unknown if hand instruments were used
Time per Q: unknown
Maintenance: at week 2, 4, 8, 12 and 16 after treatment (both groups), PI recorded, OHI given
Retreatment: none
Duration of study: 4 months
Outcomes Primary outcome: unknown
Secondary outcomes: PPD, CAL, BOP (4 sites per tooth), serum IL‐27 (see Shirmohammadi 2013 under Babaloo 2018; also serum IL‐17 And IL‐1β were evaluated)
Teeth: whole‐mouth recordings with manual probe
Pocket depth at baseline: data not split for pocket depth categories
Outcome time reported: 4‐month data used. Baseline, 2 and 4 months reported
Other outcomes: PI, MGI*
Notes *additional information found in Shirmohammadi 2013 under Babaloo 2018.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Patients were randomly assigned to two groups using toss of a coin".
Allocation concealment (selection bias) Unclear risk Insufficient information for judgement.
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "All the measurements were performed by one calibrated periodontist who was blind to the treatment groups" (additional information from Shirmohammadi 2013 under Babaloo 2018).
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Insufficient information for judgement. It is implied that all participants completed the study but not explicitly stated.
Selective reporting (reporting bias) Low risk Data reported on secondary outcomes; primary outcome not defined.
Other bias Unclear risk Baseline balance good for pocket depth; however smoking unclear. No apparent other biases.