NCT07119307

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 30, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 13, 2025

Completed
Last Updated

September 15, 2025

Status Verified

May 1, 2023

Enrollment Period

1.7 years

First QC Date

August 11, 2025

Last Update Submit

September 9, 2025

Conditions

Periodontal DiseasesIntrabony Periodontal Defect

Outcome Measures

Primary Outcomes (2)

  • relative attachment level gain

    measuring relative attachment level gain with UNC-15 probe

    6 months

  • pocket depth change

    measuring probing pocket depth changes

    6 months

Secondary Outcomes (2)

  • Tomographic defect width

    6 months

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

    6 months

Study Arms (3)

Entire Papilla Preservation Technique

PLACEBO COMPARATOR

Entire Papilla Preservation Technique alone

Procedure: Entire Papilla Preservation Technique

Entire Papilla Preservation Technique with Emdogain

ACTIVE COMPARATOR

Entire Papilla Preservation Technique with Emdogain

Procedure: Entire Papilla Preservation Surgical Technique (EPPT) alone

Entire Papilla Preservation Technique with Emdogain and Bovine Derived Xenograft

ACTIVE COMPARATOR

Entire Papilla Preservation Technique with Emdogain and Bovine Derived Xenograft

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

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 Technique
Entire Papilla Preservation Surgical Technique (EPPT) alonePROCEDURE

Entire Papilla Preservation Surgical Technique (EPPT) alone

Entire Papilla Preservation Technique with Emdogain
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)

Entire Papilla Preservation Technique with Emdogain and Bovine Derived Xenograft

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rungta College of Dental Sciences and Research

Bhilai, Chhattisgarh, 490024, India

Location

Related Publications (1)

  • Aslan S, Buduneli N, Cortellini P. Entire Papilla Preservation Technique: A Novel Surgical Approach for Regenerative Treatment of Deep and Wide Intrabony Defects. Int J Periodontics Restorative Dent. 2017 Mar/Apr;37(2):227-233. doi: 10.11607/prd.2584.

    PMID: 28196163BACKGROUND

MeSH Terms

Conditions

Periodontal Diseases

Interventions

Single Person

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Marital StatusFamily CharacteristicsDemographyPopulation CharacteristicsSocioeconomic Factors

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 11, 2025

First Posted

August 13, 2025

Study Start

May 30, 2023

Primary Completion

January 30, 2025

Study Completion

March 30, 2025

Last Updated

September 15, 2025

Record last verified: 2023-05

Locations

IN(1)