Clinical, Radiographic and Volumetric Evaluation of the Entire Papilla Preservation Technique With and Without Connective Tissue Graft in the Treatment of Periodontal Intraosseous Defects.
1 other identifier
interventional
30
1 country
3
Brief Summary
This study is to assess the impact of implementing subepithelial connective tissue graft (SCTG) in the treatment of periodontal intrabony defects with Entire Papilla Preservation Technique (EPPT) on the clinical and radiographic results after 6 and 12 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2026
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 2, 2026
CompletedFirst Posted
Study publicly available on registry
July 30, 2026
CompletedStudy Start
First participant enrolled
August 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2027
Study Completion
Last participant's last visit for all outcomes
November 30, 2027
July 30, 2026
January 1, 2026
1.2 years
April 2, 2026
July 28, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical Attachment Level gain (CAL, mm)
Clinical Attachment Level (CAL) gain, measured in millimeters (mm), defined as the change from baseline in the distance from the cemento-enamel junction (CEJ) to the base of the periodontal pocket, assessed using a calibrated periodontal probe.
6 months and 12 months
Secondary Outcomes (12)
Probing Pocket Depth (PPD, mm)
Baseline, 6 months and 12 months
Probing Pocket Depth reduction (PPD, mm)
6 months and 12 months
Clinical Attachment Level (CAL, mm)
Baseline, 6 months, and 12 months
Gingival Recession (GR, mm)
Baseline, 6 months and 12 months
Keratinized Tissue Width (KTW, mm)
Baseline, 6 months and 12 months
- +7 more secondary outcomes
Study Arms (2)
Entire Papilla Preservation Technique (EPPT) + EMD
ACTIVE COMPARATORParticipants receive periodontal regenerative surgery using the Entire Papilla Preservation Technique (EPPT) combined with enamel matrix derivative (EMD). After flap elevation and defect debridement, root surface conditioning with EDTA is performed, followed by application of enamel matrix derivative and placement of bone substitute material as needed. Flaps are repositioned and sutured for primary closure.
Entire Papilla Preservation Technique (EPPT) + EMD+ SCTG
EXPERIMENTALParticipants receive periodontal regenerative surgery using the Entire Papilla Preservation Technique (EPPT) combined with enamel matrix derivative (EMD) and subepithelial connective tissue graft (SCTG). After flap elevation and defect debridement, root surface conditioning with EDTA is performed, followed by application of enamel matrix derivative and placement of bone substitute material. A subepithelial connective tissue graft is harvested and placed at the defect site prior to flap closure.
Interventions
A microsurgical periodontal regenerative technique aimed at preserving the interdental papilla. The procedure includes flap elevation, defect debridement, root surface conditioning, application of regenerative materials, and primary wound closure.
Application of EDTA gel to the root surface to remove the smear layer and enhance regenerative outcomes.
A biologically active material applied to the root surface after EDTA conditioning to promote periodontal regeneration.
An autogenous connective tissue graft harvested from the palate and placed at the surgical site to enhance soft tissue thickness and stability.
A xenogeneic bone graft material used to support bone regeneration within the intrabony defect.
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years,
- Good compliance and good oral hygiene
- Systemically healthy
- Isolated two intrabony defects of more than 3 mm depth, combined with more than 6 mm probing depth and attachment loss (stage III/IV periodontitis) and an intrabony radiographic defect depth (DD) ≥ 3 mm, as evaluated on a digital periapical radiograph
- The associated tooth should either maintain normal pulp vitality or should have undergone root canal therapy for at least 6 months before.
You may not qualify if:
- Full-mouth plaque score ≥ 20% (O'Leary et al 1972)
- Full-mouth bleeding score ≥ 20% (Cortellini et al 1995)
- Smoking
- Systemic diseases that would adversely influence wound healing
- Medications interfering with post-operative wound healing
- Pregnant and lactating females
- Previous periodontal surgery in the examined area
- III-degree mobility
- Furcation involvement
- Pulpal pathology or inadequate endodontic treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw, Warsaw
Warsaw, Warsaw, 00-246, Poland
Department of Integrated Dentistry, University of Białystok
Bialystok, 15276, Poland
Department of Periodontology, Pomeranian Medical University Contact
Szczecin, Poland
Study Officials
- STUDY CHAIR
Bartłomiej Górski
Depatrment of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw, Warsaw
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 2, 2026
First Posted
July 30, 2026
Study Start (Estimated)
August 1, 2026
Primary Completion (Estimated)
September 30, 2027
Study Completion (Estimated)
November 30, 2027
Last Updated
July 30, 2026
Record last verified: 2026-01