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Comparison Between Two Non-surgical Periodontal Treatment Procedures With and Without Interdental Hygiene Devices in Periodontitis Patients: a Longitudinal Prospective Controlled Clinical Trial

Comparison Between Two Non-surgical Periodontal Treatment Procedures With and Without Interdental Hygiene Devices in Periodontitis Patients: a Longitudinal Prospective Controlled Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04339309
Enrollment
52
Registered
2020-04-09
Start date
2015-04-30
Completion date
2017-07-31
Last updated
2020-04-13

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

Conditions

Chronic Periodontitis

Brief summary

Periodontitis is treated by regularly clearance of the disease-causing biofilm through domestic care and dental measures (Petersilka et al., 2002, Herrera et al., 2008). Healthy gums have intact papillae occluding the interdental area. Successful brushing cleans these areas; the prophylaxis of gingivitis for such patients does therefore not require special aids. In contrast, initial attachment loss as a result of inflammation or restorative therapy leads to additional cleaning needs, since the normal brush is not able to clean interdental areas as successful as vestibular and oral surfaces (Dörfer and Staehle, 2010). It can be said that interdental brushes are the most effective tools for cleaning interdental spaces (Salzer et al., 2015). Compared with a toothbrush, they are the only tool showing better results of plaque removal and reduction of gingivitis (Slot et al., 2008). Therefore their use should not be restricted to older people with already reduced interdental papillae. A big advantage is that interdental brushes are generally easy to use. If brush sizes are chosen correctly, insertion and multiple forward and backward movement is sufficient to obtain com- plete cleaning of the interproximal surfaces. Additional cleaning by other means such as dental floss is not always necessary because interdental brushes clean approximal and subgingival surfaces sufficiently, providing the size was chosen correctly (Dörfer and Staehle, 2010). Due to the above mentioned coherences and associations, this study includes the hypothesis that patients with periodontitis would benefit from the instruction and motivation of interdental brushes within the active periodontitis therapy in comparison to a periodontitis therapy without the instructed domestic interdental hygiene by a stronger reduction of clinical inflammatory characteristics (Salzer et al., 2015). The corresponding Zero-Hypothesis says that no difference would be found between both groups.

Interventions

PROCEDURENon-surgical periodontal treatment with interdental hygiene devices
PROCEDURENon-surgical periodontal treatment without interdental hygiene devices

Sponsors

University of Kiel
CollaboratorOTHER
Cairo University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* Generalized chronic periodontitis (CP) * Generalized aggressive periodontitis (AgP) * Availability for non-surgical periodontal therapy and reevaluation after 3±1 months. * Moderate to advanced severity of periodontitis (≥30% of the sites with attachment loss ≥3mm) * Age: 18 - 70 years * ≥16 scorable teeth, without root caries

Exclusion criteria

* Localized chronic or aggressive periodontitis (\<30% diseased teeth of all teeth) * Smoking * Tumour(s) of the soft or hard tissues of the oral cavity. * Systematic disease, which include specific conditions to treat (e.g. prophylaxis of endocarditic) * Women who are aware of being pregnant or who are breastfeeding. * Forms of acute necrotizing ulcerating periodontitis

Design outcomes

Primary

MeasureTime frameDescription
Bleeding on probing3 monthsBleeding on probing (BOP) will be measured at least after the measurement of the CAL through recording bleeding sign at the site of clinical probing (six sites of each teeth).

Secondary

MeasureTime frameDescription
Probing pocket depth3 monthsProbing Pocket Depth (PPD) at every site will be assessed as the distance (mm) from the gingival margin to the apical end of the pocket using a PCP UNC-15 probe (Hu-Friedy, Chicago Ill, USA). The probe will be inserted parallel to the root surface and directed apically toward the perceived location of the apex of the root until slight resistance is felt. Probe recordings will be rounded off to the nearest millimeter mark. PPDs are measured at six areas of the tooth. These are the disto-vestibular, vestibular, mesio-vestibular, disto-lingual, lingual and the mesio-lingual. First the vestibular surface is probed and scored. Thereafter, the lingual surface is probed and scored.
Clinical attachment level (CAL)3 monthsThe CAL at every site will be measured as the distance between the cemento-enamel junction (CEJ) and the apical end of the pocket using a PCP UNC-15 probe (Hu-Friedy, Chicago Ill, USA). The probe will be placed parallel to the tooth surface and probe recordings will be rounded off to the nearest millimeter mark. A score is given to six areas of the tooth. These are the disto-vestibular, vestibular, mesio-vestibular, disto-lingual, lingual and the mesio-lingual. First the vestibular surface is probed and scored. Thereafter, the lingual surface is probed and scored.
Antibiotic use3 monthsMeasure whether antibiotics are used or not during the treatment phase by a questionnaire

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026