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Flapless Emdogain in the Treatment of Periodontal Residual Pockets

A

Arab American University (Palestine)

Status

Completed

Conditions

Chronic Periodontitis, Generalized

Treatments

Procedure: Re-instrumentation with placebo application
Procedure: Re-instrumentation with flapless Emdogain application

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Enrollment

48 patients

Sex

All

Ages

19 to 75 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

48 participants in 2 patient groups

Flapless Emdogain (FEMD) group
Experimental group
Description:
Re-instrumentation with flapless emdogain application
Treatment:
Procedure: Re-instrumentation with flapless Emdogain application
Placebo group
Active Comparator group
Description:
Re-instrumentation without flapless emdogain application
Treatment:
Procedure: Re-instrumentation with placebo application

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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