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

Sponsor

Ain Shams University (Other)

Overall Status

Recruiting

CT.gov ID

NCT06003322

Collaborator

Assiut University (Other), Egyptian Russian University (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Periodontal Attachment Loss	Procedure: non - Incised Papilla surgical approach NIPSA for intrabony defect Procedure: single-flap approach SFA	N/A

Detailed Description

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 7, 2023

Anticipated Primary Completion Date :

Aug 7, 2024

Anticipated Study Completion Date :

Sep 7, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: non - Incised Papilla surgical approach NIPSA for intrabony defect Group I will be allocated to non - Incised Papilla surgical approach NIPSA for intrabony defect with DBBM and PRF	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
Active Comparator: single-flap approach group II will be allocated to single-flap approach SFA for intrabony defect with DBBM and PRF	Procedure: 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

Arm

Intervention/Treatment

Experimental: non - Incised Papilla surgical approach NIPSA for intrabony defect

Group I will be allocated to non - Incised Papilla surgical approach NIPSA for intrabony defect with DBBM and PRF

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

Active Comparator: single-flap approach

group II will be allocated to single-flap approach SFA for intrabony defect with DBBM and PRF

Procedure: 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

Outcome Measures

Primary Outcome Measures

interproximal clinical attachment level change [at baseline ,6 and 12 months]
CAL, measured in the interproximal space from the CEJ to the base of the pocket(BP)using a millimeter periodontal probe

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	faculty of dentistry ,Assiut university	Assiut		Egypt	23145

Sponsors and Collaborators

Ain Shams University
Assiut University
Egyptian Russian University

Investigators

Study Director: ALAA T ALI, PhD, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alaa Talaat Ali, lecturer, Ain Shams University

ClinicalTrials.gov Identifier:

NCT06003322

Other Study ID Numbers:

PER243

First Posted:

Aug 21, 2023

Last Update Posted:

Aug 21, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Periodontal Attachment Loss

Study Results

No Results Posted as of Aug 21, 2023