Papilla Preservation Technique in Combination With Tooth Enamel Proteins and Animal Derived Bone Graft in Treating Isolated Bone Defects Between Teeth

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-30

Study Completion Date

2025-03-30

Brief Summary

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The present three-arm study compared the clinical and tomographic efficacy of the Entire Papilla Preservation Surgical Technique (EPPT) alone and combined with enamel matrix derivative (EMD) plus bone mineral derivedxenograph (BMDX), in the treatment of isolated, inter-dental intra-bony defects.

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Detailed Description

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This randomized controlled clinical and tomographic study included 48 sites with isolated interdental intrabony defects, divided into three groups. Group 1 (control) received EPPT alone, Group 2 received EPPT with EMD, and Group 3 received EPPT with EMD and BMDX (Fix-Oss xenograft). Clinical parameters probing pocket depth (PPD), relative attachment level (RAL), gingival recession (GR), and papilla height-were recorded at baseline and 12 months. Cone-beam computed tomography (CBCT) was used to evaluate tomographic changes including defect width, CEJ-BD, CEJ-AC, X-ray INFRA and defect angle.

Conditions

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Periodontal Diseases Intrabony Periodontal Defect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Entire Papilla Preservation Technique

Entire Papilla Preservation Technique alone

Group Type PLACEBO_COMPARATOR

Entire Papilla Preservation Technique

Intervention Type PROCEDURE

Entire Papilla Preservation Surgical Technique (EPPT) alone and combined with enamel matrix derivative (EMD) plus bone mineral derived xenograph (BMDX)

Entire Papilla Preservation Technique with Emdogain

Group Type ACTIVE_COMPARATOR

Entire Papilla Preservation Surgical Technique (EPPT) alone

Intervention Type PROCEDURE

Entire Papilla Preservation Surgical Technique (EPPT) alone

Entire Papilla Preservation Technique with Emdogain and Bovine Derived Xenograft

Group Type ACTIVE_COMPARATOR

Entire Papilla Preservation Surgical Technique (EPPT) alone and combined with enamel matrix derivative (EMD)

Intervention Type PROCEDURE

Entire Papilla Preservation Surgical Technique (EPPT) alone and combined with enamel matrix derivative (EMD)

Interventions

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Entire Papilla Preservation Technique

Entire Papilla Preservation Surgical Technique (EPPT) alone and combined with enamel matrix derivative (EMD) plus bone mineral derived xenograph (BMDX)

Intervention Type PROCEDURE

Entire Papilla Preservation Surgical Technique (EPPT) alone

Intervention Type PROCEDURE

Entire Papilla Preservation Surgical Technique (EPPT) alone and combined with enamel matrix derivative (EMD)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* stage II or III periodontitis, according to WWP 2017 classification of periodontal diseases in need of periodontal regenerative treatment for isolated intrabony defects
* single-rooted teeth/multi-rooted teeth without furcation involvement

Exclusion Criteria

* uncontrolled or poorly controlled diabetes,
* unstable or life-threatening conditions, or requiring antibiotic prophylaxis,
* History of use of medications since last 6 months (immunosuppressants and antibiotics),
* Subjects allergic to medications,
* Pregnant or lactating women, Smokers/users of other tobacco products,
* Subjects showing unacceptable oral hygiene maintenance after initial phase I therapy and
* multiple interconnected vertical defects.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes