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

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

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.

Study Overview

• Status: Unknown
• Conditions: Periodontitis; Periodontal Diseases; Intrabony Periodontal Defect; Periodontal Pocket
• Intervention / Treatment: Combination product: PPF+NCHA bone graft substitute

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
• Enrollment (Anticipated): 12
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical attachment level	Measured from the CEJ to the bottom of the gingival sulcus by William's graduated Periodontal probe in mm	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probing Depth	Measured from the gingival margin to the bottom of the gingival sulcus by William's graduated Periodontal probe in mm	6 months
Gingival Recession Depth	Measured from the CEJ to the most apical extension of the gingival margin by William's graduated Periodontal probe in mm	6 months
Plaque index	Numerical Scoring system Scores 0,1,2,3 by William's graduated Periodontal probe	6 months
Gingival index	Numerical Scoring system Scores 0,1,2,3 by William's graduated Periodontal probe	6 months
Linear bone fill	Measured from the CEJ to the deepest part of the intrabony defect using the linear measurement tool of the Digora software	6 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Alaa A Rakha, master, Cairo University; Study Director: Noha A Ghallab, professor, Cairo University

Publications and helpful links

General Publications

• 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.

Helpful Links

• reference link from PubMed

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2018
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): November 1, 2019

Study Registration Dates

• First Submitted: June 24, 2018
• First Submitted That Met QC Criteria: July 4, 2018
• First Posted (Actual): July 17, 2018

Study Record Updates

• Last Update Posted (Actual): July 17, 2018
• Last Update Submitted That Met QC Criteria: July 4, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: papilla preservation; modified papilla preservation; simplified papilla preservation; nanocrystalline hydroxyapetite; nanobone graft
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontitis; Periodontal Diseases; Periodontal Pocket
• Other Study ID Numbers: ppfrct

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No