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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Chronic Periodontitis

Intervention / Treatment
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* Procedure: Non-surgical periodontal treatment with interdental hygiene devices
* Procedure: Non-surgical periodontal treatment without interdental hygiene devices


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Kiel Center<br>Non-surgical periodontal treatment with interdental hygiene devices in periodontitis patients. | Procedure: Non-surgical periodontal treatment with interdental hygiene devices<br> <br> |
| Active Comparator: Cairo Center<br>Non-surgical periodontal treatment without interdental hygiene devices in periodontitis patients. | Procedure: Non-surgical periodontal treatment without interdental hygiene devices<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding on probing | Bleeding 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). | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probing pocket depth | Probing 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. | 3 months | 
| Clinical attachment level (CAL) | The 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. | 3 months | 
| Antibiotic use | Measure whether antibiotics are used or not during the treatment phase by a questionnaire | 3 months |