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

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.

Study Overview

• Status: Completed
• Conditions: Periodontal Diseases; Intrabony Periodontal Defect
• Intervention / Treatment: Procedure: Entire Papilla Preservation Technique; Procedure: Entire Papilla Preservation Surgical Technique (EPPT) alone; Procedure: Entire Papilla Preservation Surgical Technique (EPPT) alone and combined with enamel matrix derivative (EMD)

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.

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Chhattisgarh
    • Bhilai, Chhattisgarh, India, 490024
      • Rungta College of Dental Sciences and Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Entire Papilla Preservation Technique; Entire Papilla Preservation Technique alone	Procedure: Entire Papilla Preservation Technique; Entire Papilla Preservation Surgical Technique (EPPT) alone and combined with enamel matrix derivative (EMD) plus bone mineral derived xenograph (BMDX)
Active Comparator: Entire Papilla Preservation Technique with Emdogain	Procedure: Entire Papilla Preservation Surgical Technique (EPPT) alone; Entire Papilla Preservation Surgical Technique (EPPT) alone
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); Entire Papilla Preservation Surgical Technique (EPPT) alone and combined with enamel matrix derivative (EMD)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Rungta College of Dental Sciences and Research

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2023
• Primary Completion (Actual): January 30, 2025
• Study Completion (Actual): March 30, 2025

Study Registration Dates

• First Submitted: August 11, 2025
• First Submitted That Met QC Criteria: August 11, 2025
• First Posted (Actual): August 13, 2025

Study Record Updates

• Last Update Posted (Estimated): September 15, 2025
• Last Update Submitted That Met QC Criteria: September 9, 2025
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Periodontal Diseases; Public Health; Environment and Public Health; Socioeconomic Factors; Population Characteristics; Environment; Demography; Epidemiologic Measurements; Residence Characteristics; Family Characteristics; Home Environment
• Other Study ID Numbers: RCDSR/IEC/MDS/2023/D-35

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: For confidentiality

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes