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Completed

NCT Number: NCT05456555

The Flapless Approach in Periodontal Regeneration

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CIR Dental School

Turin, 10126, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Flapless with Enamel Matrix Derivatives (EMD)

Procedure

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.

Flapless without Enamel Matrix Derivatives (EMD)

Procedure

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.

Primary outcomes

  1. Clinical attachment level change

    Time frame: 12 months

    Clinical attachment level will be assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA)

Secondary outcomes

  1. Radiographic bone level change

    Time frame: 12 months

    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)

  2. Probing pocket depth change

    Time frame: 12 months

    Probing depth will be assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA)

Sponsors and collaborators

Lead sponsor

University of Turin, Italy

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 13, 2022
Registry last updated
Dec 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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