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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05823389
Other study ID # EMD
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2, 2019
Est. completion date December 15, 2022

Study information

Verified date April 2023
Source Arab American University (Palestine)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

48 adult patients participated in a single-centre randomized clinical trial with split- mouth design. They had presented at re-evaluation after initial non-surgical periodontal therapy (steps 1 and 2 of periodontal therapy) for generalized periodontitis with at least 2 teeth with residual probing pocket depths (PPD) ≥5 and ≤8 mm, with bleeding on probing (BOP). Two teeth with similar PPD were randomized to receive re-instrumentation either with (test) or without (control) adjunctive flapless administration of EMD. Differences in the changes of PPD and BOP from baseline to 6 and 12 months will be analysed, and the frequencies of pocket closure (PPD ≤4 mm and no BOP) will be compared


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date December 15, 2022
Est. primary completion date October 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 75 Years
Eligibility Inclusion Criteria: - at least two residual pockets with probing pocket depth (PPD) =5 and =8 mm, - bleeding on probing (BOP), - mobility =degree 1 and - no furcation involvement. Exclusion Criteria: - full mouth plaque score >20%, - uncontrolled systemic disease, - history of malignant disease in the oral cavity or previous radiotherapy in the head or neck area, - pregnant or lactating females, - drug and alcohol abuse, - smoking >10 cigarettes per day and - inadequate restorative therapy or malocclusion.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Re-instrumentation with flapless Emdogain application
Teeth with deep probing pocket depths were randomized to receive re-instrumentation with adjunctive flapless administration of EMD
Re-instrumentation with placebo application
Teeth with deep probing pocket depths were randomized to receive re-instrumentation with adjunctive placebo application

Locations

Country Name City State
Palestinian Territory, occupied Arab American University Ramallah

Sponsors (1)

Lead Sponsor Collaborator
Arab American University (Palestine)

Country where clinical trial is conducted

Palestinian Territory, occupied, 

Outcome

Type Measure Description Time frame Safety issue
Primary Differences in changes of probing pocket depths (PPD) from baseline to 6 and 12 months probing pocket depth (PPD) 12 months
Primary Differences in changes of bleeding on probing (BOP) from baseline to 6 and 12 months bleeding on probing (BOP) 12 months
Secondary frequencies of pocket closure PPD =4 mm 12 months
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