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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06003322
Enrollment
20
Registered
2023-08-21
Start date
2023-08-07
Completion date
2024-09-07
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontal Attachment Loss

Brief 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)

Detailed 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)

Interventions

PROCEDUREnon - 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

PROCEDUREsingle-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

Sponsors

Assiut University
CollaboratorOTHER
Egyptian Russian University
CollaboratorNETWORK
Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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. \-

Design outcomes

Primary

MeasureTime frameDescription
interproximal clinical attachment level changeat baseline ,6 and 12 monthsCAL, measured in the interproximal space from the CEJ to the base of the pocket(BP)using a millimeter periodontal probe

Secondary

MeasureTime frameDescription
residual probing pocket depth (PPD), pocket depth (PD) change,at at baseline ,6 and 12 months-Inter- proximal PD, measured in the interproximal space from the gingival margin to the BP measured by a millimeter periodontal probe

Countries

Egypt

Contacts

Primary ContactAlaa Ali, P.h.D
alaa.ali@dent.aun.edu.eg01003646556

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026