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

Evaluation of Entire Papilla Preservation Technique in Combination With Enamel Matrix Derivative & Bone Mineral Derived Xenograft in Isolated Interdental Intrabony Defects

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07119307

Enrollment

Registered

2025-08-13

Start date

2023-05-30

Completion date

2025-03-30

Last updated

2025-09-15

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

Conditions

Intrabony Periodontal Defect, Periodontal Diseases

Brief summary

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.

Detailed description

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.

Interventions

PROCEDUREEntire Papilla Preservation Technique

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

PROCEDUREEntire Papilla Preservation Surgical Technique (EPPT) alone

Entire Papilla Preservation Surgical Technique (EPPT) alone

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

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
relative attachment level gain	6 months	measuring relative attachment level gain with UNC-15 probe
pocket depth change	6 months	measuring probing pocket depth changes

Secondary

Measure	Time frame	Description
Tomographic defect width	6 months	measured defect width in CBCT
the distance between the cemento-enamel junction and the bottom of the defect	6 months	the distance between the cemento-enamel junction and the bottom of the defect

Countries

India

Outcome results

None listed

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