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

NCT04444063 | Unknown DMC

• 1 other identifier: PER 3-3-3
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Periodontitis Chronic Generalized Severe; Intrabony Periodontal Defect

Keywords

minimal invasive technique; NIPSA; Allograft; PRF

Outcome Measures

Primary Outcomes (1)

• Clinical attachment level gain (CAL) clinical attachment level gain (CAL)

  measured with UNC periodontal probe in mm

  12 months

Secondary Outcomes (6)

• Gingival recession (GR)

  12 months

• Pocket depth (PD)

  12 months

• Radiographic defect fill

  12 months

• Gingival bleeding

  T1 T2 (Surgical phase- 8 weeks) , T4 3- months post-surgical ,T5 6-months post-surgical ,T6 1- Year post-surgical

• Plaque index

  12 months

Study Arms (2)

NIPSA technique with Allograft plus PRF

EXPERIMENTAL

Non-incised papilla preservation technique to treat intraosseous bony defects with the addition of Allograft plus PRF

Procedure: Non-Incised Papilla Surgical Approach

NIPSA technique

ACTIVE COMPARATOR

Non-incised papilla preservation technique to treat intraosseous bony defects without the addition of Allograft plus PRF

Procedure: Non-Incised Papilla Surgical Approach

Interventions

Non-Incised Papilla Surgical Approach PROCEDURE

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.

NIPSA technique; NIPSA technique with Allograft plus PRF

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Any systemic disease that contra-indicates periodontal surgery or may affect healing.
• Smokers
• Pregnant females
• Drug abusers

Sponsors & Collaborators

• Cairo University: lead

Related Publications (1)

• 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.

  PMID: 31190409 BACKGROUND

Study Officials

• Omneya Abo-Eldahab, PHD

  Cairo University

  STUDY CHAIR

• Omneya K. Tawfeek, PHD

  Cairo University

  STUDY CHAIR

Central Study Contacts

Ahmed M. Elkady, MSc

CONTACT

01005641154; ahmedelkady442@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: single blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant

Model Details: it is a Randomized clinical trial

Study Record Dates

• First Submitted: June 19, 2020
• First Posted: June 23, 2020
• Study Start: September 1, 2020
• Primary Completion: June 1, 2023
• Study Completion: October 1, 2023
• Last Updated: June 23, 2020

Record last verified: 2020-06