RecruitingNot ApplicableNCT06070181

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

"Effectiveness of Emdogain® As an Adjunctive Therapy for Non-Surgical Periodontal Treatment- a Randomized, Controlled, Split-Mouth Design Multicenter Clinical Trial"


Sponsor

Ostergotland County Council, Sweden

Enrollment

150 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to assess the safety and effectiveness of adjunctive Emdogain® therapy in non-surgical periodontal treatment for patients with stage 3 and 4 periodontitis. The main questions it aims to answer are: * Will adjunctive treatment with Emdogain® result in a greater reduction in Bleeding on Probing and probing pocket depth compared to non-surgical periodontal treatment alone? • Will adjunctive treatment with Emdogain® lead to a greater mean Radiographic attachment level (rAL) gain per quadrant compared to non-surgical periodontal treatment alone? * Will adjunctive treatment with Emdogain® result in a lower proportion of treated teeth requiring surgery (PPD ≥6mm) at 12 months after treatment? Participants in the study will undergo the following tasks: * Screening and randomization * Receival of non-surgical periodontal treatment in all quadrants and in two quadrants adjunctive Emdogain® * 6-month follow-up assessment * 12-month follow-up assessment Clinical and radiological assesment will be performed in two quadrants treated with adjunctive Emdogain® therapy and two quadrants treated with non-surgical periodontal treatment alone. This comparison will help determine the effects of adjunctive therapy with Emdogain®. The study aims to provide insights into the safety and efficacy of adjunctive Emdogain® therapy in non-surgical periodontal treatment, specifically in patients with stage 3 and 4 periodontitis.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • Patients must meet all of the following criteria for inclusion in the study:
  • Over 18 years old
  • Stage 3 or 4 periodontitis
  • Residual pockets with probing depths from 5mm to 9mm with no furcation involvement and adequate plaque control

Exclusion Criteria3

  • Antibiotic treatment in last 3 months
  • Subgingival scaling and root planning performed in last 12 months
  • Patients for which the use of Emdogain® is contraindicated i. e. patients with uncontrolled diabetes or other uncontrolled systemic diseases, disorders or treatments that compromise wound healing, chronic high dose steroid therapy, bone metabolic diseases, radiation or other immuno-suppressive therapy and infections or vascular impairment at the surgical site.

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Interventions

DEVICEEnamel matrix derivate

'Applying Enamel matrix derivate in the periodontal pockets after completing the non-surgical periodontal treatment

PROCEDURENon-surgical periodontal treatment

No additional/adjunctive treatment with Emdogain


Locations(1)

Centre for Oral Rhabilitation

Linköping, Region Östergötland, Sweden

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NCT06070181


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