Clinical and Radiographic Evaluation of PPF With or Without NCHA Bone in Treatment of Intrabony Defects
1 other identifier
interventional
12
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2018
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2018
CompletedFirst Posted
Study publicly available on registry
July 17, 2018
CompletedStudy Start
First participant enrolled
September 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2019
CompletedJuly 17, 2018
July 1, 2018
1 year
June 24, 2018
July 4, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Probing Depth
6 months
Gingival Recession Depth
6 months
Plaque index
6 months
Gingival index
6 months
Linear bone fill
6 months
Study Arms (2)
Papilla preservation flap techniques
NO INTERVENTIONPapilla 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.
PPF+NCHA bone graft substitute
ACTIVE COMPARATORintervention: 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.
Interventions
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 .
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Related Publications (1)
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.
PMID: 19680697RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alaa A Rakha, master
Cairo University
- STUDY DIRECTOR
Noha A Ghallab, professor
Cairo University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- 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
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- resident
Study Record Dates
First Submitted
June 24, 2018
First Posted
July 17, 2018
Study Start
September 1, 2018
Primary Completion
September 1, 2019
Study Completion
November 1, 2019
Last Updated
July 17, 2018
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share