Flapless Emdogain in the Treatment of Periodontal Residual Pockets

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05823389

Enrollment

Registered

2023-04-21

Start date

2019-09-02

Completion date

2022-12-15

Last updated

2023-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Periodontitis, Generalized

Brief 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

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to 75 Years

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

* 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.

Design outcomes

Primary

Measure	Time frame	Description
Differences in changes of probing pocket depths (PPD) from baseline to 6 and 12 months	12 months	probing pocket depth (PPD)
Differences in changes of bleeding on probing (BOP) from baseline to 6 and 12 months	12 months	bleeding on probing (BOP)

Secondary

Measure	Time frame	Description
frequencies of pocket closure	12 months	PPD ≤4 mm

Countries

Palestinian Territories

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026