Flapless Emdogain in the Treatment of Periodontal Residual Pockets

NCT05823389 | Completed

• 1 other identifier: EMD
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Periodontitis, Generalized

Outcome Measures

Primary Outcomes (2)

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

  probing pocket depth (PPD)

  12 months

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

  bleeding on probing (BOP)

  12 months

Secondary Outcomes (1)

• frequencies of pocket closure

  12 months

Study Arms (2)

Flapless Emdogain (FEMD) group

EXPERIMENTAL

Re-instrumentation with flapless emdogain application

Procedure: Re-instrumentation with flapless Emdogain application

Placebo group

ACTIVE COMPARATOR

Re-instrumentation without flapless emdogain application

Procedure: Re-instrumentation with placebo application

Interventions

Re-instrumentation with flapless Emdogain application PROCEDURE

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

Flapless Emdogain (FEMD) group

Re-instrumentation with placebo application PROCEDURE

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

Placebo group

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arab American University (Palestine): lead

Study Sites (1)

Arab American University

Ramallah, 240, Palestinian Territories

Location

MeSH Terms

Conditions

Chronic Periodontitis

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 7, 2023
• First Posted: April 21, 2023
• Study Start: September 2, 2019
• Primary Completion: October 1, 2022
• Study Completion: December 15, 2022
• Last Updated: April 21, 2023

Record last verified: 2023-04

Locations

PA (1)