Comparison Between Two Non-surgical Periodontal Treatment Procedures With and Without Interdental Hygiene Devices in Periodontitis Patients: a Longitudinal Prospective Controlled Clinical Trial
Primary Purpose
Chronic Periodontitis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Non-surgical periodontal treatment with interdental hygiene devices
Non-surgical periodontal treatment without interdental hygiene devices
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Periodontitis
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Kiel Center
Cairo Center
Arm Description
Non-surgical periodontal treatment with interdental hygiene devices in periodontitis patients.
Non-surgical periodontal treatment without interdental hygiene devices in periodontitis patients.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
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.
Antibiotic use
Measure whether antibiotics are used or not during the treatment phase by a questionnaire
Full Information
NCT ID
NCT04339309
First Posted
April 7, 2020
Last Updated
April 9, 2020
Sponsor
Cairo University
Collaborators
University of Kiel
1. Study Identification
Unique Protocol Identification Number
NCT04339309
Brief Title
Comparison Between Two Non-surgical Periodontal Treatment Procedures With and Without Interdental Hygiene Devices in Periodontitis Patients: a Longitudinal Prospective Controlled Clinical Trial
Official Title
Comparison Between Two Non-surgical Periodontal Treatment Procedures With and Without Interdental Hygiene Devices in Periodontitis Patients: a Longitudinal Prospective Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
April 2015 (Actual)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
Collaborators
University of Kiel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Kiel Center
Arm Type
Active Comparator
Arm Description
Non-surgical periodontal treatment with interdental hygiene devices in periodontitis patients.
Arm Title
Cairo Center
Arm Type
Active Comparator
Arm Description
Non-surgical periodontal treatment without interdental hygiene devices in periodontitis patients.
Intervention Type
Procedure
Intervention Name(s)
Non-surgical periodontal treatment with interdental hygiene devices
Intervention Type
Procedure
Intervention Name(s)
Non-surgical periodontal treatment without interdental hygiene devices
Primary Outcome Measure Information:
Title
Bleeding on probing
Description
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).
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Probing pocket depth
Description
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.
Time Frame
3 months
Title
Clinical attachment level (CAL)
Description
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.
Time Frame
3 months
Title
Antibiotic use
Description
Measure whether antibiotics are used or not during the treatment phase by a questionnaire
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
16972401
Citation
Behle JH, Papapanou PN. Periodontal infections and atherosclerotic vascular disease: an update. Int Dent J. 2006 Aug;56(4 Suppl 1):256-62. doi: 10.1111/j.1875-595x.2006.tb00110.x.
Results Reference
background
PubMed Identifier
18724841
Citation
Herrera D, Alonso B, Leon R, Roldan S, Sanz M. Antimicrobial therapy in periodontitis: the use of systemic antimicrobials against the subgingival biofilm. J Clin Periodontol. 2008 Sep;35(8 Suppl):45-66. doi: 10.1111/j.1600-051X.2008.01260.x.
Results Reference
background
PubMed Identifier
16170976
Citation
Jared H, Zhong Y, Rowe M, Ebisutani K, Tanaka T, Takase N. Clinical trial of a novel interdental brush cleaning system. J Clin Dent. 2005;16(2):47-52.
Results Reference
background
PubMed Identifier
12013348
Citation
Petersilka GJ, Ehmke B, Flemmig TF. Antimicrobial effects of mechanical debridement. Periodontol 2000. 2002;28:56-71. doi: 10.1034/j.1600-0757.2002.280103.x.
Results Reference
background
PubMed Identifier
25581718
Citation
Salzer S, Slot DE, Van der Weijden FA, Dorfer CE. Efficacy of inter-dental mechanical plaque control in managing gingivitis--a meta-review. J Clin Periodontol. 2015 Apr;42 Suppl 16:S92-105. doi: 10.1111/jcpe.12363.
Results Reference
background
PubMed Identifier
19138177
Citation
Slot DE, Dorfer CE, Van der Weijden GA. The efficacy of interdental brushes on plaque and parameters of periodontal inflammation: a systematic review. Int J Dent Hyg. 2008 Nov;6(4):253-64. doi: 10.1111/j.1601-5037.2008.00330.x.
Results Reference
background
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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
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