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

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ClinicalTrials.gov Identifier: NCT03588507
Recruitment Status : Not yet recruiting
First Posted : July 17, 2018
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
Alaa ashraf, Cairo University

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.

Condition or disease Intervention/treatment Phase
Periodontitis Periodontal Diseases Periodontal Pocket Intrabony Periodontal Defect Combination Product: PPF+NCHA bone graft substitute Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Primary Purpose: Treatment
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
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : November 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts

Arm Intervention/treatment
No Intervention: Papilla preservation flap techniques
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.
Active Comparator: PPF+NCHA bone graft substitute
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.
Combination Product: PPF+NCHA bone graft substitute
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 Measures :
  1. Clinical attachment level [ Time Frame: 6 months ]
    Measured from the CEJ to the bottom of the gingival sulcus by William's graduated Periodontal probe in mm


Secondary Outcome Measures :
  1. Probing Depth [ Time Frame: 6 months ]
    Measured from the gingival margin to the bottom of the gingival sulcus by William's graduated Periodontal probe in mm

  2. Gingival Recession Depth [ Time Frame: 6 months ]
    Measured from the CEJ to the most apical extension of the gingival margin by William's graduated Periodontal probe in mm

  3. Plaque index [ Time Frame: 6 months ]
    Numerical Scoring system Scores 0,1,2,3 by William's graduated Periodontal probe

  4. Gingival index [ Time Frame: 6 months ]
    Numerical Scoring system Scores 0,1,2,3 by William's graduated Periodontal probe

  5. Linear bone fill [ Time Frame: 6 months ]
    Measured from the CEJ to the deepest part of the intrabony defect using the linear measurement tool of the Digora software



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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03588507


Contacts
Contact: Alaa A Rakha, master 00201098797367 dralaaashraf@yahoo.com
Contact: Weam A ElBattawy, lecturer 00201001500537 weamelbattawy@dentistry.cu.edu.eg

Sponsors and Collaborators
Cairo University
Investigators
Principal Investigator: Alaa A Rakha, master faculty of dentistry, cairo university
Study Director: Noha A Ghallab, professor faculty of dentistry, cairo university

Additional Information:
Publications of Results:
Responsible Party: Alaa ashraf, resident, Cairo University
ClinicalTrials.gov Identifier: NCT03588507     History of Changes
Other Study ID Numbers: ppfrct
First Posted: July 17, 2018    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Alaa ashraf, Cairo University:
papilla preservation
modified papilla preservation
simplified papilla preservation
nanocrystalline hydroxyapetite
nanobone graft

Additional relevant MeSH terms:
Periodontitis
Periodontal Diseases
Periodontal Pocket
Mouth Diseases
Stomatognathic Diseases