Clinical and Radiograhic Evaluation of NIPSA With and Without Allograft Plus Platelet Rich Fibrin in the Treatment of Intraosseous Defects in Stage III Periodontitis Patients
Primary Purpose
Periodontitis Chronic Generalized Severe, Intrabony Periodontal Defect
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Non-Incised Papilla Surgical Approach
Sponsored by
About this trial
This is an interventional treatment trial for Periodontitis Chronic Generalized Severe focused on measuring minimal invasive technique, NIPSA, Allograft, PRF
Eligibility Criteria
Inclusion Criteria:
- Patients with Stage III periodontitis patient having at least one tooth with two wall or combined two to three walled intraosseous defect more than or equal 3 mm deep (assessed by trans-gingival probing, radiographic examination) with clinical attachment level (CAL) more than or equal 5mm and pocket depth (PD) more than or equal 6 mm.
- Defect not extending to a root furcation area.
- Vital teeth
- No history of intake of antibiotics or other medications affecting the periodontium in the previous 6 months.
- No surgical periodontal therapy carried out in the past 6 months.
- Able to sign an informed consent form.
- Patients who are cooperative, motivated, and hygiene conscious.
- Able to come for the follow up appointment's needed.
Exclusion Criteria:
- Any systemic disease that contra-indicates periodontal surgery or may affect healing.
- Smokers
- Pregnant females
- Drug abusers
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
NIPSA technique with Allograft plus PRF
NIPSA technique
Arm Description
Non-incised papilla preservation technique to treat intraosseous bony defects with the addition of Allograft plus PRF
Non-incised papilla preservation technique to treat intraosseous bony defects without the addition of Allograft plus PRF
Outcomes
Primary Outcome Measures
Clinical attachment level gain (CAL) clinical attachment level gain (CAL)
measured with UNC periodontal probe in mm
Secondary Outcome Measures
Gingival recession (GR)
measured with UNC periodontal probe in mm
Pocket depth (PD)
measured with UNC periodontal probe in mm
Radiographic defect fill
standardized digital periapical radiograph
Gingival bleeding
Gingival bleeding score
Plaque index
Plaque Index score
Post-surgical patient Satisfaction
(1-7) point scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04444063
Brief Title
Clinical and Radiograhic Evaluation of NIPSA With and Without Allograft Plus Platelet Rich Fibrin in the Treatment of Intraosseous Defects in Stage III Periodontitis Patients
Official Title
Clinical and Radiographic Evaluation of the Non-Incised Papilla Surgical Approach With and Without Allograft Plus Platelet Rich Fibrin in Treatment of Intraosseous Defects in Stage III Periodontitis Patients: A Randomized-Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 2020 (Anticipated)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Several minimal invasive techniques have been proposed since the last decade aiming to enhance and provide adequate environment for periodontal regeneration. Harrel and Rees proposed minimally invasive surgery (MIS) in 1995 and minimal invasive surgical technique (MIST) that was introduced in 2007 and then further enforced with modified minimally invasive surgical technique (M-MIST) in 2009 . A new minimal invasive technique called Non-Incised Papilla Surgical Approach (NIPSA) was introduced in 2017. It is aims to maintain the marginal tissues integrity by placing horizontal or oblique incision apical to the defect approaching the defect through apical access.
Detailed Description
Intraosseous vertical defects are one of the consequences that could result from periodontitis, which are classified according to their architecture by the number of residual walls, defect width as well as topographic extension in relation to the tooth.
Conventional surgery done for regenerative purpose regarding vertical defects has been known to be affected by clot stability, it was reported in the literature that reduced clinical outcomes occurred when early wound failure and exposure of the treated area occurred. This led to the innovation of different minimally invasive flap techniques that aimed at reducing the surgical trauma, allowing blood clot stability, protecting the regenerating site, reducing patient discomfort postoperatively as well as minimizing surgical chair time Among these techniques are papilla preservation flaps and minimally invasive surgical approaches with papilla elevation or without papilla elevation . However, these techniques had in their design incisions related to the interdental papilla which would jeopardize and complicate the vascular integrity of the interdental tissues Non incised Papilla surgical approach is a new surgical technique introduced by Moreno Rodriguez in 2017 to maintain the marginal tissues and the papilla intact by placing a horizontal or oblique incision apical to the defect and approaching it through an apical access leaving the marginal tissues to act as a "dome " protecting the blood clot
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis Chronic Generalized Severe, Intrabony Periodontal Defect
Keywords
minimal invasive technique, NIPSA, Allograft, PRF
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
it is a Randomized clinical trial
Masking
Outcomes Assessor
Masking Description
single blinded
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NIPSA technique with Allograft plus PRF
Arm Type
Experimental
Arm Description
Non-incised papilla preservation technique to treat intraosseous bony defects with the addition of Allograft plus PRF
Arm Title
NIPSA technique
Arm Type
Active Comparator
Arm Description
Non-incised papilla preservation technique to treat intraosseous bony defects without the addition of Allograft plus PRF
Intervention Type
Procedure
Intervention Name(s)
Non-Incised Papilla Surgical Approach
Intervention Description
Horizontal or oblique incision is done on the buccal mucosa as far as possible from the marginal keratinized tissue and the inter dental papilla The horizontal/oblique incision is extended mesio-distally enough to allow proper visualization of the defect A full thickness flap is elevated apico- coronally to expose the coronal limit of the defect Scaling and root planning are done using mini-curettes and power driven ultrasonic tips with care trying to maintain fibers attached to the cementum Granulation tissue is removed with mini-curettes detached from the bony walls and removed from the base of the papilla carefully with microblades and microscissors .
1ry soft tissue closure will be performed by horizontal mattress suture 2mm from the edges of the incision as a first line of closure and then simple interrupted suture as a second line of closure using (5-0, 6-0) polypropylene suture.
Primary Outcome Measure Information:
Title
Clinical attachment level gain (CAL) clinical attachment level gain (CAL)
Description
measured with UNC periodontal probe in mm
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Gingival recession (GR)
Description
measured with UNC periodontal probe in mm
Time Frame
12 months
Title
Pocket depth (PD)
Description
measured with UNC periodontal probe in mm
Time Frame
12 months
Title
Radiographic defect fill
Description
standardized digital periapical radiograph
Time Frame
12 months
Title
Gingival bleeding
Description
Gingival bleeding score
Time Frame
T1 T2 (Surgical phase- 8 weeks) , T4 3- months post-surgical ,T5 6-months post-surgical ,T6 1- Year post-surgical
Title
Plaque index
Description
Plaque Index score
Time Frame
12 months
Title
Post-surgical patient Satisfaction
Description
(1-7) point scale
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients with Stage III periodontitis patient having at least one tooth with two wall or combined two to three walled intraosseous defect more than or equal 3 mm deep (assessed by trans-gingival probing, radiographic examination) with clinical attachment level (CAL) more than or equal 5mm and pocket depth (PD) more than or equal 6 mm.
Defect not extending to a root furcation area.
Vital teeth
No history of intake of antibiotics or other medications affecting the periodontium in the previous 6 months.
No surgical periodontal therapy carried out in the past 6 months.
Able to sign an informed consent form.
Patients who are cooperative, motivated, and hygiene conscious.
Able to come for the follow up appointment's needed.
Exclusion Criteria:
Any systemic disease that contra-indicates periodontal surgery or may affect healing.
Smokers
Pregnant females
Drug abusers
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed M. Elkady, MSc
Phone
01005641154
Ext
002
Email
ahmedelkady442@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omneya Abo-Eldahab, PHD
Organizational Affiliation
Cairo University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Omneya K. Tawfeek, PHD
Organizational Affiliation
Cairo University
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
I will check with my study chairs
Citations:
PubMed Identifier
31190409
Citation
Moreno Rodriguez JA, Ortiz Ruiz AJ, Caffesse RG. Supra-alveolar attachment gain in the treatment of combined intra-suprabony periodontal defects by non-incised papillae surgical approach. J Clin Periodontol. 2019 Sep;46(9):927-936. doi: 10.1111/jcpe.13158. Epub 2019 Jul 22.
Results Reference
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Clinical and Radiograhic Evaluation of NIPSA With and Without Allograft Plus Platelet Rich Fibrin in the Treatment of Intraosseous Defects in Stage III Periodontitis Patients
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