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Completed

NCT Number: NCT02949557

DFDBA and Xenograft (Cerabone)TM With Decortication in Intrabony Defects

DFDBA is an allograft that possesses osteoconductive and osteoinductive properties. It has the potential for osteoinduction due to increased expression of bone morphogenetic protein (BMP).Cerabone™ has shown maximum resemblance to human bone with the potential to reconstruct bone defects. Decortication is performed as a part of guided bone regeneration (GBR) procedure as it enhances the healing process.Therefore a combination of decortication and bone graft when applied in periodontal intrabony defect would enhance the regeneration of periodontium.

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Key information

Age range

25 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

There have been great strides in the management of periodontal intrabony defects, especially with the use of bone graft materials. It is necessary to choose the most appropriate material and procedure in order to obtain the desired regeneration. Among the bone grafts, Demineralised freezed dried bone allograft (DFDBA) and xenografts have shown good results in the management of intrabony defects. Recently, a novel bovine xenograft i.e., Cerabone™ has shown maximum resemblance to human bone with the potential to reconstruct bone defects. Decortication or intramarrow penetration of the bone has shown favourable results in guided bone regeneration procedures. So the goal of the present study was to check the efficacy of decortication with decalcified freeze dried bone allograft (DFDBA) and Cerabone™ bone grafts and to compare the response between the bonegrafts placed following decortication using RVG and CBCT, in intrabony defect.

The combination of decortication with bone grafts i.e., DFDBA and (Cerabone)TM can be an added advantage in the treatment of intrabony defects. To the best of the investigators knowledge no clinical trial reports this combination therapy in scientific literature. There is need for further research in this area.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age group 25-45 years
  • Moderate periodontitis with pocket probing depth more than 5 mm
  • Bilaterally similiar intrabony defects
  • systemically healthy patients
  • Good compliance

Exclusion criteria

  • medically compromised
  • Pregnant and lactating women
  • Smoking
  • teeth with mobility and furcation involvement

Treatment and study plan

Decortication + bone grafts

Procedure

Primary outcomes

  1. clinical attachment level

    Time frame: 9 months

    clinical attachment level measured in mm from cementoenamel junction to the base of the pocket

  2. Bone fill

    Time frame: 9 months

    Bone fill measured in mm in radiographs from alveolar crest to base of the pocket

  3. Pocket probing depth

    Time frame: 9 months

    pocket probing depth level measured in mm from gingival margin to base of the pocket

Secondary outcomes

  1. Plaque Index (PI)

    Time frame: 9 month

    Plaque index is measured for periodontal health

  2. Periodontal disease index

    Time frame: 9 months

    Periodontal disease index is measured for periodontal health

  3. Gingival Bleeding Index

    Time frame: 9 months

    Gingival bleeding index is measured for periodontal health

Sponsors and collaborators

Lead sponsor

Krishnadevaraya College of Dental Sciences & Hospital

Other

Registry information

Official study title

A Comparative Clinical and Radiographic Evaluation of Demineralized Freeze Dried Bone Allograft (DFDBA) and Xenograft (Cerabone)TM With Decortication in the Treatment of Periodontal Intraosseous Defects

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Oct 31, 2016
Registry last updated
Oct 31, 2016

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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