Clinical trial NCT03588507: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Periodontitis
Periodontal Diseases
Periodontal Pocket
Intrabony Periodontal Defect
Keywords: papilla preservation
modified papilla preservation
simplified papilla preservation
nanocrystalline hydroxyapetite
nanobone graft
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-07-17
Enrollment: 12
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Clinical attachment level
timeFrame: 6 months
Secondary outcomes:
measure: Probing Depth
timeFrame: 6 months
measure: Gingival Recession Depth
timeFrame: 6 months
measure: Plaque index
timeFrame: 6 months
measure: Gingival index
timeFrame: 6 months
measure: Linear bone fill
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Alaa A Rakha, master
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Noha A Ghallab, professor
role: STUDY_DIRECTOR
References:
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.