Regenerative Combined Therapy With Enamel Matrix Derivative and Biphasic Calcium Phosphate Graft

NCT02828423 | Completed Phase 4 DMC

• 1 other identifier: PER-ECL-2011-04-CM
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: The use of Enamel Matrix Derivative (EMD) when dealing with non-contained defects may be limited, as EMD does not maintain a space itself. It has been proposed the use of combined therapy, using a bone graft in combination with EMD to avoid the collapse of the flap into the bony defect during the healing time. Therefore the aim of this study is to evaluate the clinical and radiological healing response of non-contained infrabony defects following treatment with a combination of EMD and Biphasic calcium phosphate (BC) or EMD alone. Methods: Fifty-two patients with at least 1 infrabony defect \> 3mm in depth with a probing pocket depth ≥ 6mm were randomly treated with EMD/BC or EMD alone. Clinical and radiographic parameters were evaluated at baseline, 6 and 12 months after surgery. To standardize the procedure an acrylic stent and a millimetre radiographic grid were used. The primary outcome was the change in clinical attachment level (CAL). Results: Analysis of the data demonstrated a statistically significant difference from baseline within each group (p\<0.05), showing a difference in clinical and radiographic parameters at 6 and 12 months for both EMD/BC and EMD alone. However, there were no statistically significant differences between treatment groups. Conclusions: It was concluded that the treatment of non-contained infrabony defects with EMD, with or without BC, resulted in statistically significant better results after 12 months when compared to baseline measurements. In contrast, the combined approach did not result in a statistically significant improvement.

Conditions

Intrabony Periodontal Defect

Keywords

periodontal regeneration

Outcome Measures

Primary Outcomes (1)

• Clinical Attachment Gain

  Clinical attachment will be recorded in millimeters with a periodontal probe. Differences between baseline and 12 months will be calculated. Measurements will be performed by a masked and calibrated investigator with the aid of a positioning stent over teeth to obtain reproducible measurement in each time point.

  Baseline to 12 months

Secondary Outcomes (2)

• Probing pocket depth reduction

  Baseline to 12 months

• Radiograph bone fill gain

  Baseline to 12 months

Study Arms (2)

Control group

ACTIVE COMPARATOR

Regeneration therapy of non-contained intrabony defects with enamel matrix derivate (EMD) alone

Procedure: EMD

Test group

EXPERIMENTAL

Regeneration therapy of non-contained intrabony defects with enamel matrix derivate (EMD) and Biphasic Calcium phosphate (BC)

Procedure: EMD; Procedure: BC

Interventions

EMD PROCEDURE

Regenerative surgery with EMD

Control group; Test group

BC PROCEDURE

Regenerative surgery with BC

Test group

Eligibility Criteria

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

You may qualify if:

• subjects in treatment for periodontal disease with no systemic diseases or conditions that could influence the therapy outcome
• not taking any medication that would affect periodontal healing
• high standards of oral hygiene (PI \<20%)
• compliance with the maintenance program
• presence of at least 1 infrabony defect with a probing depth ≥6mm after reevaluation of the hygienic phase and an infrabony component of ≥3mm as detected on radiographs, with any angulation, and exhibiting a 1 or 2 wall intrabony defect
• presence of at least 2mm of keratinized tissue on the buccal aspect of the selected tooth and
• teeth have to be vital or properly treated endodontically.

You may not qualify if:

• subjects with any debilitating systemic disease or medication that could affect the periodontium
• heavy smokers (\>10 cigarettes/day)
• teeth with class II or III furcation involvement
• mobility \> class 2
• strict or predominantly 3-wall defects

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead

Related Publications (1)

• Losada M, Gonzalez R, Garcia AP, Santos A, Nart J. Treatment of Non-Contained Infrabony Defects With Enamel Matrix Derivative Alone or in Combination With Biphasic Calcium Phosphate Bone Graft: A 12-Month Randomized Controlled Clinical Trial. J Periodontol. 2017 May;88(5):426-435. doi: 10.1902/jop.2016.160459. Epub 2016 Dec 13.

  PMID: 27958765 DERIVED

Study Officials

• José Nart, PhD, DDS, MS

  Universitat Internacional de Catalunya

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS, MS, Associated Professor

Study Record Dates

• First Submitted: June 30, 2016
• First Posted: July 11, 2016
• Study Start: September 1, 2011
• Primary Completion: February 1, 2016
• Study Completion: March 1, 2016
• Last Updated: July 11, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will share