Flapless Emdogain in the Treatment of Periodontal Residual Pockets

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-02

Study Completion Date

2022-12-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effectiveness of Adjunctive Therapy of Emdogain®FL in Non-surgical Periodontal Treatment

NCT06070181

Periodontitis

RECRUITING NA

Enamel Matrix Derivative in Non-surgical Periodontal Treatment

NCT04449393

Periodontitis

COMPLETED NA

The Effectiveness of Root Planing and Injectable Platelet-Rich Fibrin in Smoking Patients With Periodontitis

NCT07049549

Periodontal Healing Periodontitis i-PRF

COMPLETED NA

Enamel Matrix Derivatives on Systemic Inflammation After Periodontal Therapy

NCT03544931

Periodontal Diseases

COMPLETED NA

Amelogenins and Systemic Inflammation After Periodontal Surgical Therapy

NCT03590093

Periodontal Diseases

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Periodontitis, Generalized

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Flapless Emdogain (FEMD) group

Re-instrumentation with flapless emdogain application

Group Type EXPERIMENTAL

Re-instrumentation with flapless Emdogain application

Intervention Type PROCEDURE

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

Placebo group

Re-instrumentation without flapless emdogain application

Group Type ACTIVE_COMPARATOR

Re-instrumentation with placebo application

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Re-instrumentation with flapless Emdogain application

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

Intervention Type PROCEDURE

Re-instrumentation with placebo application

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes