Perforated Collagen Membrane With Nanohydroxyapatite for Intrabony Defects

NCT03399279 | Completed DMC

• 1 other identifier: 0925-0586
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Intrabony Periodontal Defect

Keywords

nanohydroxyapatite; Perforated membrane; occlusive membrane; Aggressive periodontitis

Outcome Measures

Primary Outcomes (1)

• CAL

  Clinical attachment level

  Change from base line to 3 months and 6 months

Secondary Outcomes (1)

• DOD

  Change from base line to 6 months

Study Arms (2)

Open flap debridement & perforated&Nano

EXPERIMENTAL

Perforated collagen membrane and nano-hydroxyapatite and open flap debridement

Procedure: Open flap debridment; Other: Perforated collagen membrane; Other: Nanohydroxyapetite

Open flap debridment &Occlusive&Nano

ACTIVE COMPARATOR

Occlusive membrane and nano-hydroxyapatite and open flap debridement

Procedure: Open flap debridment; Other: Occlusive membrane; Other: Nanohydroxyapetite

Interventions

Open flap debridment PROCEDURE

Full mucoperiosteal flap reflected+ Debridement of infrabony defect

Open flap debridement & perforated&Nano; Open flap debridment &Occlusive&Nano

Perforated collagen membrane OTHER

Membrane perforations using dental needle

Open flap debridement & perforated&Nano

Occlusive membrane OTHER

Biotech collagen membrane

Open flap debridment &Occlusive&Nano

Nanohydroxyapetite OTHER

Nanbone Particles

Open flap debridement & perforated&Nano; Open flap debridment &Occlusive&Nano

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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…

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Conditions

Aggressive Periodontitis

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

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: Dr.

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: January 16, 2018
• Study Start: December 17, 2014
• Primary Completion: September 15, 2016
• Study Completion: March 25, 2017
• Last Updated: January 17, 2018

Record last verified: 2018-01