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Completed

NCT Number: NCT07119307

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

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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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Rungta College of Dental Sciences and Research

Bhilai, Chhattisgarh, 490024, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Entire Papilla Preservation Technique

Procedure

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) alone

Procedure

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)

Primary outcomes

  1. relative attachment level gain

    Time frame: 6 months

    measuring relative attachment level gain with UNC-15 probe

  2. pocket depth change

    Time frame: 6 months

    measuring probing pocket depth changes

Secondary outcomes

  1. Tomographic defect width

    Time frame: 6 months

    measured defect width in CBCT

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

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Rungta College of Dental Sciences and Research

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 13, 2025
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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