Non - Incised Papilla Versus Single Flap Technique In The Reconstruction Of Intrabony Defect

Periodontal Attachment Loss Clinical Trial

Official title:

Non - Incised Papilla Versus Single Flap Technique In The Reconstruction Of Intrabony Defect: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06003322
• Other study ID #: PER243
• Status: Recruiting
• Phase: N/A
• Start date: August 7, 2023
• Est. completion date: September 7, 2024

Study information

• Verified date: August 2023
• Source: Ain Shams University
• Contact: Alaa Ali, P.h.D
• Phone: 01003646556
• Email: alaa.ali[@]dent.aun.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The present study will aim to assess the effectiveness of the non-Incised Papilla surgical approach NIPSA used for the surgical debridement of deep intraosseous defects compared to the single-flap approach SFA.

Primary outcome: interproximal clinical attachment level gain Secondary outcomes: residual probing pocket depth (PPD), pocket depth (PD) reduction, recession (REC), location of the tip of the papilla (TP), width of the keratinized tissue (KT), wound closure (WC), supra-alveolar attachment gain (SUPRA-AG)

Description:

The present study will aim to assess the effectiveness of the non-Incised Papilla surgical approach NIPSA used for the surgical debridement of deep intraosseous defects compared to the single-flap approach SFA.

Primary outcome: interproximal clinical attachment level gain Secondary outcomes: residual probing pocket depth (PPD), pocket depth (PD) reduction, recession (REC), location of the tip of the papilla (TP), width of the keratinized tissue (KT), wound closure (WC), supra-alveolar attachment gain (SUPRA-AG)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 7, 2024
• Est. primary completion date: August 7, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• - Age > 18 years

• Diagnosis with stage III-IV periodontitis.

• Presence of one or more intrabony defects with probing pocket depth (PPD) > 5 mm and radiographic defect depth > 4 mm.

• Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) < 30% (measured at four sites per tooth).

• No relevant systemic condition or disease.

Exclusion Criteria:

Third molars and teeth with type III mobility or with an incorrect endodontic or restorative treatment.

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Related Conditions & MeSH terms

• Periodontal Attachment Loss

Intervention

Procedure:
• non - Incised Papilla surgical approach NIPSA for intrabony defect
As described by Rodríguez and Caffesse in 2018, a single incision apical to the defect ,on the buccal aspect, only one apical horizontal or oblique incision will be made in the alveolar mucosa, as far removed as possible from the interdental papillae and marginal keratinized tis- sues. Following flap reflection, the bony defect will be examined carefully. Root planing is performed,. Flap closure will be performed by horizontal mattress sutures, placed 3 mm away from the borders, will be used as the first line of closure, promoting connective tissue contact between both edges of the incision, and single interrupted sutures will then be placed as a second line of closure. Using 5/0 polypropylene monofilament suture, Assut, Swiss
• single-flap approach SFA
As described by Trombelli et al 2010, A horizontal, butt-joint incision will be performed at the interdental papilla 1-2 mm coronal to the bone crest (as detected through pre-operative bone sounding). -A buccal mucoperiosteal envelope flap will be elevated by using a microsurgical periosteal elevator, leaving the residual portion of the interdental supracrestal soft tissues undetached.Flap closure will be performed by a horizontal internal mattress suture,will be performed at the base of the papilla, and a second internal mattress suture (vertical or horizontal) was performed between the most coronal portion of the flap and the most coronal portion of the palatal/lingual papilla. Using a resorbable suture

Locations

Country	Name	City	State
Egypt	faculty of dentistry ,Assiut university	Assiut

Sponsors (3)

Lead Sponsor	Collaborator
Ain Shams University	Assiut University, Egyptian Russian University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	interproximal clinical attachment level change	CAL, measured in the interproximal space from the CEJ to the base of the pocket(BP)using a millimeter periodontal probe	at baseline ,6 and 12 months
Secondary	residual probing pocket depth (PPD), pocket depth (PD) change,	-Inter- proximal PD, measured in the interproximal space from the gingival margin to the BP measured by a millimeter periodontal probe	at at baseline ,6 and 12 months