Jönsson 2009.

Methods	Trial design: parallel (2 arms) Location: Department of Periodontology, Sweden Number of centres: 1 Study Duration: recruitment March 2006 to March 2007. Participants followed‐up at 12 months
Participants	Participants: participants were recruited among subjects with moderate to advanced periodontitis referred to the clinic and examined during the period from March 2006 to March 2007 Inclusion criteria: participants clinically diagnosed with chronic periodontitis and scheduled to undergo a dental hygiene treatment (i.e. non‐surgical periodontal debridement and intervention influencing oral hygiene), aged between 20 and 65, literate in Swedish, and had a plaque index (PlI) according to Silness 1964 of ≥ 0.3. The criteria for PlI were set for 2 reasons. Firstly, a high standard of oral hygiene and a plaque level between 20% and 40% is suggested as a level compatible with maintenance of periodontal health (Axelsson 2004; Lang 2003). Secondly, as both interventions aimed to improve oral hygiene habits, subjects with low plaque scores would have clinical efforts focused on other aspects besides oral hygiene Exclusion criteria: "...if they knew that they could not be available during any part of the study period, suffered from a serious disease that precluded regular sessions, and if explorative periodontal surgery was necessary before the dental hygiene treatment" Age at baseline (years): intervention group: 52.4 ± 8.4; control group: 50.1 ± 10.3 Gender: intervention group: male: 25 (43.9%), female: 32 (56.1%); control group: male: 28 (50%), female: 28 (50%) Number randomised: 113 (intervention group: 57; control group: 56) Number evaluated: 107 (intervention group: 52; control group: 55)
Interventions	Intervention: the individually tailored oral health educational programme was based on the perspective of behavioural medicine (i.e. an integration of cognitive behavioural principles and non‐surgical periodontal treatment). The programme comprised 7 separate components with different tactics for tailoring each individual's personal goals regarding oral health and dental hygiene habits Initiation and analysis of knowledge, expectations, and motivation: initially, an interview with open‐ended questions ascertained the patients knowledge of periodontal disease, self‐care habits, and attitude towards oral hygiene, as well as outcome expectations and experiences from earlier treatment. The extent to which information about dental diseases was provided depended on each patients prior knowledge. The patient formulated (in writing) 3 to 5 personal general long‐term goals related to oral health that were the most important to them Analysis of oral hygiene behaviour: based on the above data, the dental hygienist made recommendations related to self‐care interventions that were discussed with the patient. Disclosing solution was used to illustrate any current oral biofilm and to initiate a discussion related to oral hygiene aids that might support the patients oral health goal. The patients motivation to use various oral hygiene aids was explored. A guiding principle was to introduce only 1 oral hygiene aid at each session, which allowed the patient to use the chosen aid properly and at the desired frequencies, before any new aids were introduced Practice of manual dexterity for oral hygiene aids: the practice of manual dexterity was introduced when the patients oral hygiene aid was chosen. Instruction sessions on what to do and how to do it were performed by the wash basin in front of a mirror to make the circumstances as near to a home routine as possible Individual goals for oral hygiene behaviour: at the end of each session, the patients self‐efficacy and readiness to change an oral hygiene habit was explored through a direct question. Subsequently, the oral hygiene procedures, how, when, and where to use the desired oral hygiene aid or aids, and which area should be given particular attention to until the next session were discussed and agreed upon. The action plan for oral self‐care to the next session was formulated in writing. Patients were encouraged to start using the oral hygiene aid they deemed to have the best chance of being successful in reaching the intermediate goal Continuous self‐monitoring: a short structured diary was provided to the patients for keeping records on their self‐care between sessions. Recordings included the aids used, frequency and when they were used, as well as associated factors that facilitated use or created barriers to use. The diary was discussed and analysed at the next appointment. Positive experiences were encouraged, problems were identified, and possible solutions to the problems were discussed Generalization of behaviour: when all self‐care aids had been introduced and practiced, they had to be co‐ordinated to function together. The individuals preference, knowledge, and capacity to adapt to necessary oral hygiene aids differed between aids. The dental hygienist allowed the self‐care process to develop in a way that supported individuals to proceed at their own pace Maintenance of oral hygiene behaviour and prevention of relapse: the patient was informed that relapses are common during behavioural change (Wilson 1992). Strategies for maintaining already achieved goals for oral hygiene were discussed. Specific risk situations for interdental cleaning relapse were identified (e.g. summer holiday, periods of work overload), and problem‐solving strategies were discussed. The discussions focused on situations in which oral hygiene was facilitated and how to find solutions to the problems the patient encountered. If difficult/demanding situations were identified, a plan was constructed to prepare the patient on how to handle these situations. If there were signs of a relapse to previous oral hygiene habits, the disadvantages and advantages were discussed Control: the control conditions were chosen to be equivalent to the best possible routine oral health preventive programme for patients with periodontal problems. The programme used corresponded to the description by Nyman 1984 and by Rylander 1997. The programme (labelled individual educational programme) has been tested on young adults with satisfactory results (Hugoson 2007) First session Periodontal status is demonstrated and discussed Structured information is given about the periodontal disease, its consequences, the role of careful and correct brushing twice a day, and interdental cleaning once a day Oral hygiene instructions after use of disclosing solution The dental hygienist decides and gives prescriptions on which oral hygiene aids the subjects should use and encourages the patient to do interdental cleaning before toothbrushing, preferably in the evening The subjects are asked to demonstrate and practice the cleaning technique in their own mouth The subjects are informed their own engagement is crucial for successful treatment outcome Second and following sessions The oral hygiene status is checked with a disclosure solution New instructions and adjustments of aids and technique are discussed and demonstrated if necessary New information is given if the dental hygienist considers it necessary or if the subjects ask questions about periodontal disease or oral hygiene Prophylaxis provided: in both groups, the participants visited the dental hygienist once a week until the scaling treatment was finished and there was an oral hygiene control performed after 1 month Quote: "Non‐surgical treatment and supportive periodontal care programme: non‐surgical root surface debridement was integrated into both programmes and undertaken during the initial dental hygiene treatment (visits 1 to 5), mainly performed with hand instruments (LMs Gracys curette of 5 various designs and LMs Svärdström 1/3 and 2/4). There was some supplementary scaling after the 3‐month follow‐ up and during the supportive maintenance care. At each session for both groups, the teeth were cleaned with polishing paste AV 170, and with flossing on proximal surfaces. For both groups, supportive maintenance care was scheduled every third month after the initial dental hygiene treatment, i.e. 3 and 6 months after the 3‐month follow‐up. The supportive maintenance care sessions included checking oral hygiene status with disclosure solutions, and if necessary, re‐instruction. For the experimental group these sessions included relapse prevention procedures and, when needed new goals for oral hygiene practise were discussed" Member of dental team delivering intervention: hygienist Frequency of intervention: intervention group: median number of intervention visits: 9; control group: median number of intervention visits: 8 Intensity of intervention (length of time): appointment time was approximately 60 minutes for each session up to the 3‐month follow‐up, and approximately 45 minutes for the maintenance period. In the intervention group, an extra 10 minutes was needed for the first 2 sessions Setting: secondary care Disease level: moderate to advanced periodontitis
Outcomes	"Probing pocket depth (PPD) measured at 6 surfaces of each tooth, and bleeding on probing (BoP) in connection with the measurement of periodontal pockets. The presence of plaque was recorded according to Silness & Löe (Silness 1964) PlI. In the present study, criteria 2 and 3 were combined, i.e. all visible plaque was judged as the same amount. The presence of gingival inflammation was recorded according to the criteria for the gingival index (GI) of Löe & Silness (Löe 1963). Experience from patients treated for periodontal disease at the clinic indicates that few patients have spontaneous bleeding and ulcerations; therefore, criteria 2 and 3 were considered to be equally severe. Thus, the highest score for both PlI and GI was 2. Both PlI and GI were recorded on the buccal, lingual, mesial, and distal tooth surfaces of all teeth. The mesial and distal surfaces were recorded from the lingual perspective. To minimize the risk of underestimating PlI and GI scores, the assessment was performed from the lingual aspect, as proximal surfaces are more accessible from the lingual aspect for the observer, but are probably more difficult for the individual patient when performing their oral hygiene. The assessments for PlI, GI, PPD, and BoP were performed with a mirror and a periodontal probe (CC Williams Probe 1‐2‐3‐5‐7‐8‐9‐10, Hu‐Friedys, Chicago, IL, USA)" "Oral hygiene behaviour was assessed through questionnaires covering oral self‐care habits such as frequency of toothbrushing and interdental cleaning, type of toothbrush and interdental cleaning aid, and time and place for oral cleaning. The toothbrushing and interdental cleaning were classified into 2 categories: brushing at least twice a day/less often and, cleaning proximal surfaces once a day/less often" "To evaluate participants' opinion about the interventions and satisfaction with the treatment, 6 questions were posed at the 12‐month follow‐up: (1) performance of oral self‐care (much better, better, no difference, and worse) compared with before treatment; (2) satisfaction with oral health (much more satisfied, more satisfied, and no difference, worse) compared with before treatment; (3) compliance with skills obtained during the treatment (daily, several times a week, some times per week, a couple of times during a month, seldom/never); (4) likelihood to maintain new habits (very likely, likely, fairly likely, and not likely); (5) satisfaction with care given by the dental hygienist (very satisfied, satisfied, fairly unsatisfied, and very unsatisfied); and (6) whether the treatment had been worthwhile (time and cost)(yes, absolutely, yes to some extent, neither yes nor no, and no)"
Notes	Funding: "This study was supported by the Swedish Research Council, Uppsala County Council, Swedish Patent Revenue Fund for Research in Preventive Odontology, Pfizer Oral Care Award, and the support of the authors institutions" Sample size calculation: "A power calculation, with data from a previous study (Jönsson 2006), based on the detection of a difference in the mean GI interproximally of 20% between treatment groups indicated that 75 participants were required in each group (α = 0.05, β = 0.2)" "The power analyses revealed that about 150 participants were required for the study. Although the desired number of participants was not reached further inclusion was discontinued for 2 reasons. First, the examiner was unable to participate in the whole process of the requirement and there were difficulties in introducing a new examiner to the study with short notice, and second, the original power analysis was based on an intervention judged as being less effective than the present one. Therefore, the effect size was probably underestimated" Adverse effects: not reported Declarations/conflicts of interest: "The authors declare that there are no conflicts of interest in this study"
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Participants were randomly allocated to an individually tailored oral health educational programme (experimental group) or to a standard treatment programme (control group). The randomization was made in blocks of various sizes by a random computer table"
Allocation concealment (selection bias)	Low risk	Quote: "Allocation concealment was secured by (i) having a person not involved with the clinic perform the randomization i.e. neither the examiner nor the therapist could influence the allocation of group belongings and (ii) providing the dental hygienists with sealed consecutively numbered envelopes containing only the assignment for an individual subject. The dental hygienist had not met the patient before the assignment. The sample was stratified for smoking and allocated to the 2 dental hygienists who performed the treatment"
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote: "A randomized, evaluator‐blinded, controlled trial with 2 different active treatments was performed" Comment: study reported as evaluator‐blinded. Blinding of participants was not possible; it is unclear the influence this would have on the risk of bias for this domain
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "The same examiner, who was blind to group membership, performed all clinical measurements throughout the course of the study" Comment: the examiner did not know which group the participants they were assessing had been assigned to
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "6 participants (4 women and 2 men) dropped out during the study period. In the experimental group, 1 participant discontinued treatment before the intervention started due to economic reasons and a further 2 were lost at the 3‐month follow‐up; 1 became seriously ill and 1 moved temporarily from the county, but came back into the study at the 12‐month follow‐up. Another 2 participants dropped out between the 3‐ and the 12‐month follow‐up. In the control group, 1 participant discontinued treatment"
Selective reporting (reporting bias)	Low risk	Probing pocket depths not reported in primary publication but subsequently reported
Other bias	Low risk	No apparent other bias