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Clinical and Radiographic Evaluation of PPF With or Without NCHA Bone in Treatment of Intrabony Defects

Primary Purpose

Periodontitis, Periodontal Diseases, Periodontal Pocket

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PPF+NCHA bone graft substitute
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring papilla preservation, modified papilla preservation, simplified papilla preservation, nanocrystalline hydroxyapetite, nanobone graft

Eligibility Criteria

25 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patient-related criteria:

    • Patient consulting in the outpatient clinic.
    • Able to tolerate surgical periodontal procedures.
    • Patient ready to perform oral hygiene instructions.
    • Compliance with the maintenance program.
    • Provide informed consent.
    • Accepts the 6 months follow-up period.

Teeth related criteria:

  • Mature permanent tooth.
  • Tooth with two or three-walled intra-bony defect, CAL ≥ 5mm with intra osseous defect ≥ 3mm.

Exclusion Criteria:

  • Patient-related criteria:

    • Medically compromised patients.
    • Pregnant or nursing women.
    • Uncooperative patients.
    • Smokers.

Teeth related criteria:

  • Teeth with one wall intra-bony defect.
  • Teeth with supra-bony defects.
  • Teeth with grade II or III mobility.
  • Teeth with proximal carious defects or proximal faulty restorations.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Active Comparator

    Arm Label

    Papilla preservation flap techniques

    PPF+NCHA bone graft substitute

    Arm Description

    Papilla preservation flap techniques will be conducted to gain access to the intrabony defects. In the narrow interproximal spaces (≤2 mm), incision with the preservation of the buccal papilla according to the simplified papilla preservation technique will be applied. Whereas, in the wide interdental spaces (>2 mm), the modified papilla preservation technique will be applied. Vertical or horizontal mattress sutures and additional interrupted single sutures will be performed to obtain primary closure of the interdental space.

    intervention: papilla preservation flap techniques + nanocrystalline hydroxyapatite bone graft substitute Same surgical techniques and procedures will be performed. Before suturing the flap, nanocrystalline hydroxyapatite bone graft substitute(Dentaurum, Germany) will be placed within the defect up to the existing level of the alveolar crest and care will be taken not to overfill the defect. The mucoperiosteal flaps will be repositioned and secured in place using non-resorbable # 6-0-suturing material. Vertical or horizontal mattress sutures and additional interrupted single sutures will be performed to obtain primary closure of the interdental space.

    Outcomes

    Primary Outcome Measures

    Clinical attachment level
    Measured from the CEJ to the bottom of the gingival sulcus by William's graduated Periodontal probe in mm

    Secondary Outcome Measures

    Probing Depth
    Measured from the gingival margin to the bottom of the gingival sulcus by William's graduated Periodontal probe in mm
    Gingival Recession Depth
    Measured from the CEJ to the most apical extension of the gingival margin by William's graduated Periodontal probe in mm
    Plaque index
    Numerical Scoring system Scores 0,1,2,3 by William's graduated Periodontal probe
    Gingival index
    Numerical Scoring system Scores 0,1,2,3 by William's graduated Periodontal probe
    Linear bone fill
    Measured from the CEJ to the deepest part of the intrabony defect using the linear measurement tool of the Digora software

    Full Information

    First Posted
    June 24, 2018
    Last Updated
    July 4, 2018
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03588507
    Brief Title
    Clinical and Radiographic Evaluation of PPF With or Without NCHA Bone in Treatment of Intrabony Defects
    Official Title
    Clinical and Radiographic Evaluation of Papilla Preservation Flap With or Without Nanocrystalline Hydroxyapatite Bone Graft for Management of Periodontal Intrabony Defects: A Randomized Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 1, 2018 (Anticipated)
    Primary Completion Date
    September 1, 2019 (Anticipated)
    Study Completion Date
    November 1, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study is meant to assess clinically and radiographically the possible predictable results regarding the use of nanocrystalline hydroxyapatite bone graft substitute together with papilla preservation flap versus papilla preservation flap alone in the treatment of periodontal intrabony defects. Patients will be randomly assigned to either test or control group. The two groups will be equally prepared for both surgical procedures. Then the decision of which group will receive (PPF techniques + Nanocrystalline hydroxyapatite bone graft) and which will receive (PPF techniques only) will be taken.
    Detailed Description
    Treatment of intrabony defects has been indicated mainly to decrease the residual probing depths and so improve tooth prognosis. However, the rationale behind periodontal regeneration was to decrease the pocket depth, improve clinical attachment level and achieve bone fill of severely compromised tooth. However, application of all regenerative strategies needed to be protected by stable soft tissues to avoid exposure and bacterial contamination. That's why modified and simplified papilla preservation flap techniques were developed to maintain the primary closure of interdental sites. The modified papilla preservation technique was developed in order to achieve and maintain primary closure of the flap and to increase the ability to create space for regeneration in the interdental area. The modified papilla preservation technique could be successfully applied in sites in which the interdental space width is at least 2 mm at the most coronal portion of the papilla and in conjunction with a variety of regenerative materials as bone grafts. When interdental sites were narrower, a different papilla preservation procedure had been proposed, the simplified papilla preservation flap In the past years, different Alloplastic synthetic bone graft materials had shown clinical acceptance in the treatment of periodontal osseous defects.Recently, it has been claimed that there were promising results from using nano-sized ceramics as a class of bone graft substitutes due to their improved osseointegration properties. That's why a synthetic nanocrystalline hydroxyapeptite bone grafting material has been introduced for the augmentation of intrabony defects. This gave the nanocrystalline hydroxyapatite bone graft many advantages such as providing a close contact with the surrounding tissues, bioresorbability and extremely high number of nano-sized particles and molecules on the surface.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Periodontitis, Periodontal Diseases, Periodontal Pocket, Intrabony Periodontal Defect
    Keywords
    papilla preservation, modified papilla preservation, simplified papilla preservation, nanocrystalline hydroxyapetite, nanobone graft

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Masking Description
    the records of the study participants will be assigned code numbers and the results will be assessed by a third party . coding will not be broken until all assessment and statistics will be completed
    Allocation
    Randomized
    Enrollment
    12 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Papilla preservation flap techniques
    Arm Type
    No Intervention
    Arm Description
    Papilla preservation flap techniques will be conducted to gain access to the intrabony defects. In the narrow interproximal spaces (≤2 mm), incision with the preservation of the buccal papilla according to the simplified papilla preservation technique will be applied. Whereas, in the wide interdental spaces (>2 mm), the modified papilla preservation technique will be applied. Vertical or horizontal mattress sutures and additional interrupted single sutures will be performed to obtain primary closure of the interdental space.
    Arm Title
    PPF+NCHA bone graft substitute
    Arm Type
    Active Comparator
    Arm Description
    intervention: papilla preservation flap techniques + nanocrystalline hydroxyapatite bone graft substitute Same surgical techniques and procedures will be performed. Before suturing the flap, nanocrystalline hydroxyapatite bone graft substitute(Dentaurum, Germany) will be placed within the defect up to the existing level of the alveolar crest and care will be taken not to overfill the defect. The mucoperiosteal flaps will be repositioned and secured in place using non-resorbable # 6-0-suturing material. Vertical or horizontal mattress sutures and additional interrupted single sutures will be performed to obtain primary closure of the interdental space.
    Intervention Type
    Combination Product
    Intervention Name(s)
    PPF+NCHA bone graft substitute
    Intervention Description
    nanocrystalline hydroxyapatite bone graft is a a newly developed HA containing about 65% water and 35% nanostructured apatite particles. This gave the nanocrystalline hydroxyapatite bone graft many advantages such as providing a close contact with the surrounding tissues, bioresorbability and extremely high number of nano-sized particles and molecules on the surface .
    Primary Outcome Measure Information:
    Title
    Clinical attachment level
    Description
    Measured from the CEJ to the bottom of the gingival sulcus by William's graduated Periodontal probe in mm
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Probing Depth
    Description
    Measured from the gingival margin to the bottom of the gingival sulcus by William's graduated Periodontal probe in mm
    Time Frame
    6 months
    Title
    Gingival Recession Depth
    Description
    Measured from the CEJ to the most apical extension of the gingival margin by William's graduated Periodontal probe in mm
    Time Frame
    6 months
    Title
    Plaque index
    Description
    Numerical Scoring system Scores 0,1,2,3 by William's graduated Periodontal probe
    Time Frame
    6 months
    Title
    Gingival index
    Description
    Numerical Scoring system Scores 0,1,2,3 by William's graduated Periodontal probe
    Time Frame
    6 months
    Title
    Linear bone fill
    Description
    Measured from the CEJ to the deepest part of the intrabony defect using the linear measurement tool of the Digora software
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patient-related criteria: Patient consulting in the outpatient clinic. Able to tolerate surgical periodontal procedures. Patient ready to perform oral hygiene instructions. Compliance with the maintenance program. Provide informed consent. Accepts the 6 months follow-up period. Teeth related criteria: Mature permanent tooth. Tooth with two or three-walled intra-bony defect, CAL ≥ 5mm with intra osseous defect ≥ 3mm. Exclusion Criteria: Patient-related criteria: Medically compromised patients. Pregnant or nursing women. Uncooperative patients. Smokers. Teeth related criteria: Teeth with one wall intra-bony defect. Teeth with supra-bony defects. Teeth with grade II or III mobility. Teeth with proximal carious defects or proximal faulty restorations.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Alaa A Rakha, master
    Phone
    00201098797367
    Email
    dralaaashraf@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Weam A ElBattawy, lecturer
    Phone
    00201001500537
    Email
    weamelbattawy@dentistry.cu.edu.eg
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alaa A Rakha, master
    Organizational Affiliation
    Cairo University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Noha A Ghallab, professor
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    19680697
    Citation
    Heinz B, Kasaj A, Teich M, Jepsen S. Clinical effects of nanocrystalline hydroxyapatite paste in the treatment of intrabony periodontal defects: a randomized controlled clinical study. Clin Oral Investig. 2010 Oct;14(5):525-31. doi: 10.1007/s00784-009-0325-x. Epub 2009 Aug 13.
    Results Reference
    result
    Links:
    URL
    https://www.ncbi.nlm.nih.gov/pubmed/19680697
    Description
    reference link from PubMed

    Learn more about this trial

    Clinical and Radiographic Evaluation of PPF With or Without NCHA Bone in Treatment of Intrabony Defects

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