Flapless Emdogain in the Treatment of Periodontal Residual Pockets

Chronic Periodontitis, Generalized Clinical Trial

Official title:

The Use of Flapless Enamel Matrix Derivative in Treating Periodontal Residual Pockets: A Single-centre Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05823389
• Other study ID #: EMD
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Chronic Periodontitis
• Chronic Periodontitis, Generalized
• Periodontitis

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