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

Intrabony Periodontal Defect Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04444063
• Other study ID #: PER 3-3-3
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2020
• Est. completion date: October 2023

Study information

• Verified date: June 2020
• Source: Cairo University
• Contact: Ahmed M. Elkady, MSc
• Phone: 01005641154
• Email: ahmedelkady442[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: October 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Intrabony Periodontal Defect
• Periodontitis
• Periodontitis Chronic Generalized Severe

Intervention

Procedure:
• Non-Incised Papilla Surgical Approach
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (1)

Moreno Rodríguez 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical attachment level gain (CAL) clinical attachment level gain (CAL)	measured with UNC periodontal probe in mm	12 months
Secondary	Gingival recession (GR)	measured with UNC periodontal probe in mm	12 months
Secondary	Pocket depth (PD)	measured with UNC periodontal probe in mm	12 months
Secondary	Radiographic defect fill	standardized digital periapical radiograph	12 months
Secondary	Gingival bleeding	Gingival bleeding score	T1 T2 (Surgical phase- 8 weeks) , T4 3- months post-surgical ,T5 6-months post-surgical ,T6 1- Year post-surgical
Secondary	Plaque index	Plaque Index score	12 months
Secondary	Post-surgical patient Satisfaction	(1-7) point scale	12 months