Clinical trial NCT05029089: Modified Entire Papilla Preservation Technique For Treatment Of Intrabony Defects. Clinical Trial.
Official title: Modified Entire Papilla Preservation Technique (MEPPT) For Periodontal Regenerative Treatment Of Intrabony Defects. A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Periodontitis
Regeneration
Keywords: Papilla Preservation Technique
Regenerative Treatment
Allograft
Emdogain
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2021-08-31
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Regeneration of periodontal tissues is the primary goal of periodontal surgery regenerative procedures. Both resorbable and nonresorbable barrier membranes have been widely used to receive periodontal regeneration, as well as different types of biomaterial have been investigated. Enamel matrix derivative (EMD, Emdogain, Straumann) become popular for periodontal regeneration, especially that membrane exposure due to bacterial contamination may deteriorate periodontal regeneration and wound healing especially in the interproximal areas. Hence different surgical procedures have been proposed to preserve interdental papilla. 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 by providing a tunnel- like undermining incision.

The completely preserved papillae improve wound healing process, stabilize the blood clot and the volume of interdental tissue. EMD and bone substitutes (allograft) are applied in the defect to promote periodontal regeneration. By using subepithelial connective tissue graft (sCTG) better quality (thickness) of soft tissue can be achieved. This clinical report describes surgical approach using modified papilla preservation technique for regenerative periodontal therapy. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Periodontal parameters measured before surgery.
timeFrame: 1-7 days before surgery
measure: Periodontal parameters measured during surgery.
timeFrame: During surgery
measure: Periodontal parameters measured on basis of X-ray
timeFrame: 1-7 days before surgery
Secondary outcomes:
measure: Periodontal parameters measured after surgery.
timeFrame: 12 months after surgery
Other outcomes:
measure: Patient-reported outcomes based on VAS scales
timeFrame: 2 weeks after surgery
measure: Patient-reported outcomes based on VAS scales
timeFrame: 2 weeks after surgery
measure: Patient-reported outcomes based on VAS scales
timeFrame: 2 weeks after surgery
Locations:
city: Warsaw
country: Poland
facility: Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw
state: Mazowsze
Study officials:
affiliation: Department of Periodontal and Oral Mucosa Diseases in Warsaw
name: Renata Górska, Professor
role: STUDY_CHAIR
References: