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CompletedNCT05823389Updated Apr 21, 2023

Flapless Emdogain in the Treatment of Periodontal Residual Pockets

An interventional study of Re-instrumentation with flapless Emdogain application and Re-instrumentation with placebo application in Chronic Periodontitis, Generalized, sponsored by Arab American University (Palestine). Completed at 1 site in Palestinian Territory, occupied. Open to participants aged 19 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-21.

Sponsored by Arab American University (Palestine) · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 7 months after the study started (first participant enrolled Sep 2019, registered Apr 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
19 Years to 75 Years
Sex
All
01

Study 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

02

Conditions studied

  • Chronic Periodontitis, Generalized
03

In context

Periodontitis

1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.

This study's enrollment of 48 is close to the median of 45 across 1,191 interventional studies indexed under Periodontitis.

Browse Periodontitis studies →

Lead sponsor

Arab American University (Palestine) is the lead sponsor of 12 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    Flapless Emdogain (FEMD) group

    Re-instrumentation with flapless emdogain application

    Procedure: Re-instrumentation with flapless Emdogain application

  • Active comparator
    Placebo group

    Re-instrumentation without flapless emdogain application

    Procedure: Re-instrumentation with placebo application

Interventions

  • ProcedureRe-instrumentation with flapless Emdogain application

    Teeth with deep probing pocket depths were randomized to receive re-instrumentation with adjunctive flapless administration of EMD

  • ProcedureRe-instrumentation with placebo application

    Teeth with deep probing pocket depths were randomized to receive re-instrumentation with adjunctive placebo application

06

What researchers measure

Primary outcomes

  1. Differences in changes of probing pocket depths (PPD) from baseline to 6 and 12 months

    probing pocket depth (PPD)

    Time frame: 12 months

  2. Differences in changes of bleeding on probing (BOP) from baseline to 6 and 12 months

    bleeding on probing (BOP)

    Time frame: 12 months

Secondary outcomes

  1. frequencies of pocket closure

    PPD ≤4 mm

    Time frame: 12 months

07

Study locations

1 site
  • Arab American University
    Ramallah, 240, Palestinian Territory, occupied
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05823389
Lead sponsor
Arab American University (Palestine)
Responsible party
Mahmoud Abu-Ta'a (Associate Professor, Arab American University (Palestine)) — Principal investigator
First posted
Apr 21, 2023
Start date
Sep 2, 2019
Primary completion
Oct 1, 2022
Completion
Dec 15, 2022
Last update
Apr 21, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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