Modified Entire Papilla Preservation Technique For Treatment Of Intrabony Defects. Clinical Trial.

Periodontitis Clinical Trial

— MEPPT  

Official title:

Modified Entire Papilla Preservation Technique (MEPPT) For Periodontal Regenerative Treatment Of Intrabony Defects. A Randomized Clinical Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05029089
• Other study ID #: WUM.Perio.04
• Status: Recruiting
• Phase: N/A
• Start date: September 10, 2021
• Est. completion date: September 1, 2023

Study information

• Verified date: August 2021
• Source: Medical University of Warsaw
• Contact: Beata Wyrebek, PhD
• Phone: +48692013589
• Email: beatawyrebek[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: September 1, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Periodontitis
• Regeneration

Intervention

Procedure:
• Modified Entire Papilla Preservation Technique (MEPPT) For Periodontal Regenerative Treatment Of Intrabony Defects.
Surgical approach using modified papilla preservation technique for regenerative periodontal therapy.

Device:
• Emdogain (EMD), Biomaterials (allograft, subepithelial connective tissue graft/sCTG)
Surgical approach using modified papilla preservation technique and devices for regenerative periodontal therapy.

Procedure:
• Modified Entire Papilla Preservation Technique (MEPPT) with Emdogain For Periodontal Regenerative Treatment Of Intrabony Defect
Surgical approach using modified papilla preservation technique and Emdogain for regenerative periodontal therapy.
• Modified Entire Papilla Preservation Technique (MEPPT) with Emdogain and Allograft For Periodontal Regenerative Treatment Of Intrabony Defect
Surgical approach using modified papilla preservation technique and Emdogain and Allograft for regenerative periodontal therapy.
• Modified Entire Papilla Preservation Technique (MEPPT) with Emdogain and Allograft and sCTG For Periodontal Regenerative Treatment Of Intrabony Defect
Surgical approach using modified papilla preservation technique and Emdogain and Allograft and sCTG for regenerative periodontal therapy.

Locations

Country	Name	City	State
Poland	Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw	Warsaw	Mazowsze

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient-reported outcomes based on VAS scales	Questionnaires: Scale 1: Pain after surgery (during recent 2 weeks) from 0 (no pain) to 10 (very big pain)	2 weeks after surgery
Other	Patient-reported outcomes based on VAS scales	Scale 2: Eating disturbance (during recent 2 weeks) from 0 (no eating disturbance) to 10 (very big disturbance)	2 weeks after surgery
Other	Patient-reported outcomes based on VAS scales	Scale 3: Daily functioning disturbance (during recent 2 weeks) from 0 (no daily functioning disturbance) to 10 (very big daily functioning disturbance)	2 weeks after surgery
Primary	Periodontal parameters measured before surgery.	Probing pocket depth (PPD) MEASURED IN MILIMETERS: distance from the gingival margin to the bottom of the gingival sulcus; Clinical attachment level (CAL) MEASURED IN MILIMETERS: distance from the cementoenamel junction to the bottom of the gingival sulcus; Recession height (RH) MEASURED IN MILIMETERS: distance from the cementoenamel junction to the gingival margin; Width of keratinized tissue (WKT) MEASURED IN MILIMETERS: distance between the most apical point of the gingival margin and the mucogingival junction; Gingival thickness (GT) MEASURED IN MILIMETERS: thickness of the gingiva measured 2-3 mm apical to the gingival margin	1-7 days before surgery
Primary	Periodontal parameters measured during surgery.	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).; CEJ- BD, distance between cementoenamel junction and the bottom of the bone defect MEASURED IN MILIMETERS	During surgery
Primary	Periodontal parameters measured on basis of X-ray	CEJ-MB: distance between cementoenamel junction (CEJ) and the crest of the marginal bone (MB) MEASURED IN MILIMETERS; CEJ- BD: distance between cementoenamel junction (CEJ) and the bottom of the defect (BD) MEASURED IN MILIMETERS	1-7 days before surgery
Secondary	Periodontal parameters measured after surgery.	Probing pocket depth (PPD): distance from the gingival margin to the bottom of the gingival sulcus; Clinical attachment level (CAL): distance from the cementoenamel junction to the bottom of the gingival sulcus; Recession height (RH): distance from the cementoenamel junction to the gingival margin; Width of keratinized tissue (WKT): distance between the most apical point of the gingival margin and the mucogingival junction; Gingival thickness (GT): thickness of the gingiva measured 2-3 mm apical to the gingival margin; Radiographic evaluation: Radiographical bone- filling of the intrabony defect; CEJ- MB: distance between cementoenamel junction and the crest of the marginal bone; CEJ- BD, distance between cementoenamel junction and the bottom of the bone defect; ALL ABOVE PARAMETERS ARE MEASURED IN MILIMETERS	12 months after surgery