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

Phase 4CompletedNCT07119307

Rungta College of Dental Sciences and Research58 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Periodontal Diseases Intrabony Periodontal Defect

Interventions

Entire Papilla Preservation TechniquePROCEDURE

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

Entire Papilla Preservation Surgical Technique (EPPT) alonePROCEDURE

Entire Papilla Preservation Surgical Technique (EPPT) alone

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

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Rungta College of Dental Sciences and Research

Bhilai, Chhattisgarh, India

Outcomes

Primary Outcomes

relative attachment level gain

measuring relative attachment level gain with UNC-15 probe

Time frame: 6 months

pocket depth change

measuring probing pocket depth changes

Time frame: 6 months

Secondary Outcomes

Tomographic defect width

measured defect width in CBCT

Time frame: 6 months

the distance between the cemento-enamel junction and the bottom of the defect

Time frame: 6 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.