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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03588507
Enrollment
12
Registered
2018-07-17
Start date
2018-09-01
Completion date
2019-11-01
Last updated
2018-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intrabony Periodontal Defect, Periodontal Diseases, Periodontal Pocket, Periodontitis

Keywords

papilla preservation, modified papilla preservation, simplified papilla preservation, nanocrystalline hydroxyapetite, nanobone graft

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.

Interventions

COMBINATION_PRODUCTPPF+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 .

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
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

Eligibility

Sex/Gender
ALL
Age
25 Years to 50 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Clinical attachment level6 monthsMeasured from the CEJ to the bottom of the gingival sulcus by William's graduated Periodontal probe in mm

Secondary

MeasureTime frameDescription
Probing Depth6 monthsMeasured from the gingival margin to the bottom of the gingival sulcus by William's graduated Periodontal probe in mm
Gingival Recession Depth6 monthsMeasured from the CEJ to the most apical extension of the gingival margin by William's graduated Periodontal probe in mm
Plaque index6 monthsNumerical Scoring system Scores 0,1,2,3 by William's graduated Periodontal probe
Gingival index6 monthsNumerical Scoring system Scores 0,1,2,3 by William's graduated Periodontal probe
Linear bone fill6 monthsMeasured from the CEJ to the deepest part of the intrabony defect using the linear measurement tool of the Digora software

Contacts

Primary ContactAlaa A Rakha, master
dralaaashraf@yahoo.com00201098797367
Backup ContactWeam A ElBattawy, lecturer
weamelbattawy@dentistry.cu.edu.eg00201001500537

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026