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Perforated Collagen Membrane With Nanohydroxyapatite for Intrabony Defects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03399279
Recruitment Status : Completed
First Posted : January 16, 2018
Last Update Posted : January 17, 2018
Information provided by (Responsible Party):
Hesham Mohammed Abdallah, Ain Shams University

Brief Summary:

The ultimate goal of periodontal therapy is the regeneration of periodontal tissues which have been destroyed due to periodontal disease. Different modalities have been proposed to obtain regeneration of periodontal tissues employing various bone grafts, bone substitute materials, guided tissue regeneration (GTR), combination of bone grafts or bone substitutes with GTR, and growth factors.

So, a new, fully synthetic, nanocrystalline, unsintered, phase-pure hydroxyapatite (nano-HA) has been suggested as a potential material for enhancing periodontal and bone regeneration since its chemical composition and crystalline structure correspond to the calcium phosphate component of natural bone and may have greater potential for resorption compared with sintered hydroxyapatite.

A study performed in 2012, on 14 patients with paired intrabony periodontal defects of ≥4 mm participated in split mouth design study. The defects in each subject were randomly selected to receive nano-HA paste in conjunction with papilla preservation flaps or papilla preservation flaps alone. Probing bone levels from a customized acrylic stent and probing pocket depths were measured at baseline and again 6 months following surgery. No differences in any of the investigated parameters were observed at baseline between the two groups. Healing was uneventful in all patients. Both treatments resulted in significant improvements between baseline and 6 months in all clinical and radio-graphic parameters. In conclusion, they found that the nano crystalline hydroxyapatite bone graft in combination with collagen membrane demonstrated clinical advantages beyond that achieved by open flap debridement alone.

The concept of porous guided tissue membrane has been tested recently as a modality that could stimulate bone formation of critical sized bone defects. Kim and co-workers claimed that asymmetrically porous GBR membranes with dual BMP-2 and ultrasound stimulation may be promising for the clinical treatment of delayed and insufficient bone healing. For guided tissue regeneration in periodontal therapy, membrane perforations could allow for gingival stem cells and periosteal cells to take part in supracrestal regeneration. The perforated section of the membranes would stabilize supracrestal fibrin clot through mechanical interlocking of fibrin strands with the membrane pores providing more membrane and clot stability. It has been suggested that regenerative failures may result when the tensile strength of the fibrin clot is exceeded, resulting in a tear and a long junctional epithelium type attachment.

Condition or disease Intervention/treatment Phase
Intrabony Periodontal Defect Procedure: Open flap debridment Other: Perforated collagen membrane Other: Occlusive membrane Other: Nanohydroxyapetite Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Study Of Perforated Versus Non Perforated Collagen Membrane Combined With Nanohydroxyapatite In The Management Of Intrabony Defects
Actual Study Start Date : December 17, 2014
Actual Primary Completion Date : September 15, 2016
Actual Study Completion Date : March 25, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

Arm Intervention/treatment
Experimental: Open flap debridement & perforated&Nano
Perforated collagen membrane and nano-hydroxyapatite and open flap debridement
Procedure: Open flap debridment
Full mucoperiosteal flap reflected+ Debridement of infrabony defect

Other: Perforated collagen membrane
Membrane perforations using dental needle

Other: Nanohydroxyapetite
Nanbone Particles

Active Comparator: Open flap debridment &Occlusive&Nano
Occlusive membrane and nano-hydroxyapatite and open flap debridement
Procedure: Open flap debridment
Full mucoperiosteal flap reflected+ Debridement of infrabony defect

Other: Occlusive membrane
Biotech collagen membrane

Other: Nanohydroxyapetite
Nanbone Particles

Primary Outcome Measures :
  1. CAL [ Time Frame: Change from base line to 3 months and 6 months ]
    Clinical attachment level

Secondary Outcome Measures :
  1. DOD [ Time Frame: Change from base line to 6 months ]
    Depth of Defect (From cemento enamel junction to defect base)

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Patients free from any systemic diseases as evidenced by health using Burket's Oral Medicine health history questionnaire. (Glick, 2008)
  • Patients' age range from 25 to 50 years old.
  • Each patient should have at least two contralateral intrabony defects which fulfill the following criteria: ** Probing depth ≥ 5 mm.

    • Clinical attachment loss ≥ 5 mm.
    • Radiographic evidence of vertical bone loss using periapical radiographs.
  • Patients are should be willing to participate in the study and should be able to return for the follow up visits.

Exclusion Criteria:

  • Patients with history of periodontal surgery or medications including antibiotics and non-steroidal anti-inflammatory drugs for at least 3 months prior to the initiation of the study.
  • Pregnant females as well as breast feeding mothers.
  • Smokers.
  • Vulnerable groups as prisoners, mentally disabled, etc…
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Responsible Party: Hesham Mohammed Abdallah, Dr., Ain Shams University Identifier: NCT03399279    
Other Study ID Numbers: 0925-0586
First Posted: January 16, 2018    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hesham Mohammed Abdallah, Ain Shams University:
Perforated membrane
occlusive membrane
Aggressive periodontitis