The Flapless Approach in Periodontal Regeneration

Study Overview
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Brief Summary
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The present investigation is designed in order to compare the radiographic and clinical effectiveness of flapless procedure performed alone or in combination with enamel matrix derivatives in the periodontal regenerative treatment of deep intrabony defects in patients with moderate or severe periodontitis. The study will have a follow-up of 12 months.

Official Title
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The Flapless Approach With and Without Enamel Matrix Derivatives in the Regenerative Treatment of Intrabony Defects: a Randomized Controlled Clinical Trial

Conditions
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Periodontitis, Adult, Intrabony Periodontal Defect

Intervention / Treatment
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* Procedure: Flapless with Enamel Matrix Derivatives (EMD)
* Procedure: Flapless without Enamel Matrix Derivatives (EMD)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of periodontitis stage III or IV; presence of at least one tooth with ≥6 mm associated with a radiographic intrabony defect ≥3 mm at least 2 months after the completion of non-surgical therapy; a full-mouth plaque score and full-mouth bleeding score <15% at the time of the experimental procedure; signed informed consent. Exclusion Criteria: relevant medical disorders contraindicating periodontal surgery or detrimental to periodontal healing; consumption of drugs known to affect periodontal status; pregnancy and lactation; third molars, teeth with furcation involvement or inadequate endodontic treatment and/or prosthetic restoration; heavy smokers >10 cigarettes per day.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Flapless with Enamel Matrix Derivatives (EMD)<br>Closed non-surgical treatment of periodontal intrabony defects with the combined use of Enamel Matrix Derivatives (EMD). | Procedure: Flapless with Enamel Matrix Derivatives (EMD)<br>* Experimental sites will receive a closed non-surgical treatment with a combined use of minicurettes and ultrasonic instruments with thin and delicate tips. Teeth will be instrumented until no residual calculus could be detected. A visualization of the root surface will be accomplished under magnification by using dental loups 4.0X. In the test group, the roots will be conditioned with 24% ethylenediaminetetraacetic acid (EDTA) for 2 minutes. After rinsing with sterile saline, enamel matrix derivatives (EMD) will be applied on the dried root surface.<br>|
| Active Comparator: Flapless alone<br>Closed non-surgical treatment of periodontal intrabony defects without any adjunct. | Procedure: Flapless without Enamel Matrix Derivatives (EMD)<br>* Experimental sites will receive a closed non-surgical treatment with a combined use of minicurettes and ultrasonic instruments with thin and delicate tips. Teeth will be instrumented until no residual calculus could be detected. A visualization of the root surface will be accomplished under magnification by using dental loups 4.0X. No adjunct will be administered.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical attachment level change | Clinical attachment level will be assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic bone level change | Periapical standardized radiographs will be taken by a clinician masked to the clinical measurements using the paralleling technique and individually customized bite-blocks (RINN XCP Film Holding Instruments, Dentsply, York, USA) | 12 months | 
| Probing pocket depth change | Probing depth will be assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA) | 12 months |