Modified Entire Papilla Preservation Technique For Treatment Of Intrabony Defects. Clinical Trial.
MEPPT
1 other identifier
interventional
15
1 country
1
Brief Summary
Regeneration of periodontal tissues is the primary goal of periodontal surgery regenerative procedures. Most techniques include an incision of the interdental papilla associated with defect. That may impair the volume and integrity of interdental tissues. Azzi et al. proposed a novel technique (Entire Papilla Preservation Technique, EPPT) for bone regeneration to secure the integrity of interdental papillae. This study will search for differences in regeneration therapy of isolated interdental intrabony between Modified Entire Papilla Preservation Technique (MEPPT) alone and combined with EMD, demineralised freeze- dried bone allograft and sCTG. Moreover the aim of this study was to evaluate the clinical applicability and one- year outcomes in the regenerative treatment of isolated deep intrabony defects.
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 Sep 2021
Typical duration for not_applicable
1 active site
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
July 19, 2021
CompletedFirst Posted
Study publicly available on registry
August 31, 2021
CompletedStudy Start
First participant enrolled
September 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2023
CompletedOctober 12, 2021
August 1, 2021
1.3 years
July 19, 2021
October 11, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Periodontal parameters measured before surgery.
1. Probing pocket depth (PPD) MEASURED IN MILIMETERS: distance from the gingival margin to the bottom of the gingival sulcus 2. Clinical attachment level (CAL) MEASURED IN MILIMETERS: distance from the cementoenamel junction to the bottom of the gingival sulcus 3. Recession height (RH) MEASURED IN MILIMETERS: distance from the cementoenamel junction to the gingival margin 4. Width of keratinized tissue (WKT) MEASURED IN MILIMETERS: distance between the most apical point of the gingival margin and the mucogingival junction 5. Gingival thickness (GT) MEASURED IN MILIMETERS: thickness of the gingiva measured 2-3 mm apical to the gingival margin
1-7 days before surgery
Periodontal parameters measured during surgery.
1. Intrabony component defects architecture after debridement MEASURED IN MILIMETERS(depth: distance between the crest of the marginal bone and the deepest location of the osseous defect, width: horizontal distance from the root surface to the alveolar bone crest). 2. CEJ- BD, distance between cementoenamel junction and the bottom of the bone defect MEASURED IN MILIMETERS
During surgery
Periodontal parameters measured on basis of X-ray
1. CEJ-MB: distance between cementoenamel junction (CEJ) and the crest of the marginal bone (MB) MEASURED IN MILIMETERS 2. CEJ- BD: distance between cementoenamel junction (CEJ) and the bottom of the defect (BD) MEASURED IN MILIMETERS
1-7 days before surgery
Secondary Outcomes (1)
Periodontal parameters measured after surgery.
12 months after surgery
Other Outcomes (3)
Patient-reported outcomes based on VAS scales
2 weeks after surgery
Patient-reported outcomes based on VAS scales
2 weeks after surgery
Patient-reported outcomes based on VAS scales
2 weeks after surgery
Study Arms (4)
Experimental: Entire Papilla Preservation Modified Technique (EPPMT)
EXPERIMENTALProcedure: The surgical site was anesthetized with articaine-epinephrine. After buccal intracervicular incision on vestibular aspects of two teeth surrounding the intrabony defect, a beveled vertical releasing incision was made in the buccal gingiva of the tooth affected by the intrabony defect, on the opposite site to the intrabony defect and extended beyond the mucogingival line to provide access to the intrabony defect. A buccal full thickness mucoperiosteal flap extending from the vertical incision to the defect-associated papilla and neigboring tooth was elevated (subperiosteal tunnel). Interdental tunnel under the papillary tissue was elevated to the lingual bone crest. Granulation tissue and calculus from the inner aspect of interdental papilla was removed. Microsurgical suturing technique with 7-0 materials was performed. Vertical incision was closed with simple single sutures, whereas due to modification of the original technique additional sling suture was applied.
Entire Papilla Preservation Modified Technique + EMD
ACTIVE COMPARATORProcedure: The surgical site was anesthetized with articaine-epinephrine. After buccal intracervicular incision on vestibular aspects of two teeth surrounding the intrabony defect, a beveled vertical releasing incision was made in the buccal gingiva of the tooth affected by the intrabony defect, on the opposite site to the intrabony defect and extended beyond the mucogingival line to provide access to the intrabony defect. A buccal full thickness mucoperiosteal flap extending from the vertical incision to the defect-associated papilla and neigboring tooth was elevated. Interdental tunnel under the papillary tissue was elevated to the lingual bone crest. Granulation tissue and calculus from the inner aspect of interdental papilla was removed. 24%EDTA was applied on the exposed root surface for 2 minutes, than rinsed and EMD was applied. Vertical incision was closed with simple single sutures(7-0),whereas due to modification of the original technique additional sling suture was applied.
EPP Modified Technique+EMD+allograft
ACTIVE COMPARATORProcedure:The surgical site was anesthetized with articaine-epinephrine. After buccal intracervicular incision on vestibular aspects of two teeth surrounding the intrabony defect, a beveled vertical releasing incision was made in the buccal gingiva of the tooth affected by the intrabony defect, on the opposite site to the intrabony defect and extended beyond the mucogingival line to provide access to the intrabony defect. A buccal full thickness mucoperiosteal flap extending from the vertical incision to the defect-associated papilla and neigboring tooth was elevated. Interdental tunnel under the papillary tissue was elevated to the lingual bone crest. Granulation tissue and calculus from the inner aspect of interdental papilla was removed.24%EDTA was applied on the exposed root surface, than rinsed and EMD and bone substitute was applied. Vertical incision was closed with simple single sutures, whereas due to modification of the original technique additional sling suture was applied.
EPP Modified Technique+EMD+allograft+sCTG
ACTIVE COMPARATORProcedure: After buccal intracervicular incision on vestibular aspects of two teeth surrounding the intrabony defect, a beveled vertical releasing incision was made in the buccal gingiva of the tooth affected by the intrabony defect, on the opposite site to the intrabony defect and extended beyond the mucogingival line to provide access to the intrabony defect. A buccal full thickness mucoperiosteal flap extending from the vertical incision to the defect-associated papilla and neigboring tooth was elevated. Interdental tunnel under the papillary tissue was elevated to the lingual bone crest. Granulation tissue and calculus from the inner aspect of papilla was removed.24%EDTA was applied on the exposed root surface, than rinsed and EMD and bone substitute was applied. sCTG taken form palate was sutured to the inner part of mucosa flap. Vertical incision was closed with simple single sutures, whereas due to modification of the original technique additional sling suture was applied.
Interventions
Surgical approach using modified papilla preservation technique for regenerative periodontal therapy.
Surgical approach using modified papilla preservation technique and devices for regenerative periodontal therapy.
Surgical approach using modified papilla preservation technique and Emdogain for regenerative periodontal therapy.
Surgical approach using modified papilla preservation technique and Emdogain and Allograft for regenerative periodontal therapy.
Surgical approach using modified papilla preservation technique and Emdogain and Allograft and sCTG for regenerative periodontal therapy.
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years (age 18-60 years), both genders
- Good compliance and good oral hygiene
- Systemically healthy
- Isolated intrabony defect of more than 3 mm depth, combined with more than 6 mm probing depth and attachment loss (stage III/IV periodontitis)
- The area of the intrabony defect should not exceed the lingual surface area of the root
- The morphology of the intrabony defect will be detected during the operation and finally determined whether the patient would be enrolled in the trial.
- 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 index ≥ 20% (Ainamo \& Bay 1975)
- Full-mouth sulcus bleeding index ≥ 15% (Mühlemann \& Son 1971)
- Smoking
- Systemic diseases with compromised healing potential of infectious diseases
- Drugs affecting periodontal health / healing
- Pregnant and lactating females
- Previous periodontal surgery in the examined area
- Affected teeth with 3° mobility
- Furcation involvement
- Acute periapical inflammation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw
Warsaw, Mazowsze, 00-246, Poland
Related Publications (1)
Gorski B, Jakubowska S, Wyrebek B. Entire Papilla Preservation Technique with Enamel Matrix Proteins and Allogenic Bone Substitutes for the Treatment of Isolated Intrabony Defects: A 3-Year Follow-Up of a Prospective Case Series. J Clin Med. 2025 Mar 30;14(7):2374. doi: 10.3390/jcm14072374.
PMID: 40217825DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Renata Górska, Professor
Department of Periodontal and Oral Mucosa Diseases in Warsaw
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2021
First Posted
August 31, 2021
Study Start
September 10, 2021
Primary Completion
December 30, 2022
Study Completion
September 1, 2023
Last Updated
October 12, 2021
Record last verified: 2021-08