Evaluation of Enamel Matrix Derivative as an Adjunct to Minimally Invasive Non-surgical Treatment of Intrabony Defects.

NCT03622255 | Completed

• 1 other identifier: 09/23-11-2017
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Aim: The aim of this prospective, randomized, parallel arm, blind, controlled clinical trial is to compare the clinical and radiographic outcomes following regenerative treatment of intrabony periodontal defects using a Minimally Invasive Non-Surgical Technique (MINST) with or without the application of Enamel Matrix Derivative (EMD) Research Hypothesis: The hypothesis is that the adjunctive application of EMD will enhance the clinical and radiographic results of minimally invasive non- surgical treatment of intrabony defects. Radiographic bone fill will be the primary outcome of the research, whereas CAL gain and PD reduction will constitute the secondary outcomes.

Conditions

Periodontal Diseases

Keywords

Intrabony defects; Minimally invasive non-surgical technique; Enamel Matrix Derivative

Outcome Measures

Primary Outcomes (1)

• Radiographic bone fill

  Bone level in the intrabony defect

  Change from baseline to 12 months

Secondary Outcomes (2)

• Clinical attachment gain

  Change from baseline to 12 months

• Pocket depth reduction

  Change from baseline to 12 months

Other Outcomes (7)

• Recession

  Change from baseline to 12 months

• Full mouth plaque score

  Change from baseline to 12 months

• Full mouth bleeding score

  Change from baseline to 12 months

Study Arms (2)

MINST

OTHER

Minimally invasive non-surgical technique (MINST): Root instrumentation under local anesthesia using specific hand instruments (micro- curettes) and delicate piezon ultrasonic instruments in the area of intraosseous defect.

Procedure: MINST

MINST with EMD

ACTIVE COMPARATOR

Minimally invasive non-surgical technique (MINST) with application of Enamel Matrix Derivative (EMD): Root instrumentation under local anesthesia using micro- curettes and delicate piezon ultrasonic instruments in the area of intraosseous defect. Experimental intervention by application of EDTA gel for 2 minutes on the root surface of the involved tooth, followed by rinsing with saline, drying and application of Enamel Matrix Derivative gel, to fill the defect.

Procedure: MINST with EMD

Interventions

MINST PROCEDURE

Minimally invasive non-surgical technique (MINST) for the treatment of intrabony defects has been compared with minimally invasive surgical treatment of these defects and has shown to achieve similar beneficial clinical results. In this study MINST will be used as the control treatment.

MINST

MINST with EMD PROCEDURE

Enamel matrix derivative (EMD) has been widely used in the surgical treatment of periodontal intrabony defects, using a minimally invasive surgical technique (MINST). Recent studies have suggested that this product could also be used in the non-surgical treatment of intrabony defects using a minimally invasive technique with very good results. This study will evaluate the effect of enamel matrix derivative in the non-surgical treatment of periodontal intrabony defects when a minimally invasive technique is used. Besides clinical measurements, radiographic analysis will also be performed to evaluate the treatment results.

MINST with EMD

Eligibility Criteria

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

You may qualify if:

• Be at least 18 years of age with a diagnosis of periodontitis.
• Have at least one isolated interproximal intrabony defect on a single-rooted tooth or a mandibular molar not extending to the furcation area with radiographic depth ranging between 3 mm-7 mm, pocket depth and clinical attachment loss ≥6 mm and radiographic defect angle ≤ 35o
• Proper oral hygiene: full-mouth plaque score (FMPS) ≤20% και full-mouth bleeding score (FMBS) ≤20%
• Systemically healthy (absence of systemic conditions that can affect the treatment outcome of periodontal therapy)

You may not qualify if:

• Pregnant or lactating female
• Current acute infection
• Non- surgical periodontal treatment the last 6 months or surgical periodontal treatment the last 12 months
• Teeth having an improper endodontic therapy with clinical signs of infection or subgingival restorations
• Tooth mobility 2nd- 3rd degree
• History of radiation therapy in the head and neck region

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

Aristotle University of Thessaloniki, School of Dentistry

Thessaloniki, Thessaloniki, 54124, Greece

Location

Related Publications (21)

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• Cortellini P, Tonetti MS. Improved wound stability with a modified minimally invasive surgical technique in the regenerative treatment of isolated interdental intrabony defects. J Clin Periodontol. 2009 Feb;36(2):157-63. doi: 10.1111/j.1600-051X.2008.01352.x.

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• Ribeiro FV, Casarin RC, Palma MA, Junior FH, Sallum EA, Casati MZ. Clinical and microbiological changes after minimally invasive therapeutic approaches in intrabony defects: a 12-month follow-up. Clin Oral Investig. 2013 Sep;17(7):1635-44. doi: 10.1007/s00784-012-0855-5. Epub 2012 Oct 5.

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• Nibali L, Pometti D, Chen TT, Tu YK. Minimally invasive non-surgical approach for the treatment of periodontal intrabony defects: a retrospective analysis. J Clin Periodontol. 2015 Sep;42(9):853-859. doi: 10.1111/jcpe.12443. Epub 2015 Sep 29.

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• Aimetti M, Ferrarotti F, Mariani GM, Romano F. A novel flapless approach versus minimally invasive surgery in periodontal regeneration with enamel matrix derivative proteins: a 24-month randomized controlled clinical trial. Clin Oral Investig. 2017 Jan;21(1):327-337. doi: 10.1007/s00784-016-1795-2. Epub 2016 Apr 5.

  PMID: 27044318 BACKGROUND

• Anoixiadou S, Parashis A, Vouros I. Enamel matrix derivative as an adjunct to minimally invasive non-surgical treatment of intrabony defects: A randomized clinical trial. J Clin Periodontol. 2022 Feb;49(2):134-143. doi: 10.1111/jcpe.13567. Epub 2021 Nov 9.

  PMID: 34708441 DERIVED

MeSH Terms

Conditions

Periodontal Diseases

Interventions

emerin

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Ioannis Vouros, DDS, Ph.D

  Aristotle University Of Thessaloniki

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Preventive Dentistry, Periodontology and Implant Biology

Model Details: A software (www.randomizer.org) will be used by one of the investigators who will not participate in the clinical and radiographic measurements nor the therapeutic intervention, to generate a block randomization. Thus, participants will be randomized in one of the two groups in a way that there is no difference between the two groups regarding the initial depth of the intrabony defect. In patients with more than one intrabony defects meeting the inclusion criteria, a second randomization scheme with the same software will take place, to determine which will be included. The randomization results will be placed in sealed envelopes accessible only to the principal investigator and opened for each patient after the end of MINST to determine if EMD will be applied or not.

Study Record Dates

• First Submitted: July 21, 2018
• First Posted: August 9, 2018
• Study Start: May 5, 2018
• Primary Completion: March 15, 2021
• Study Completion: March 15, 2021
• Last Updated: June 11, 2024

Record last verified: 2024-06

Locations

GR (1)