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

Primary Purpose

Periodontitis, Regeneration

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Modified Entire Papilla Preservation Technique (MEPPT) For Periodontal Regenerative Treatment Of Intrabony Defects.
Emdogain (EMD), Biomaterials (allograft, subepithelial connective tissue graft/sCTG)
Modified Entire Papilla Preservation Technique (MEPPT) with Emdogain For Periodontal Regenerative Treatment Of Intrabony Defect
Modified Entire Papilla Preservation Technique (MEPPT) with Emdogain and Allograft For Periodontal Regenerative Treatment Of Intrabony Defect
Modified Entire Papilla Preservation Technique (MEPPT) with Emdogain and Allograft and sCTG For Periodontal Regenerative Treatment Of Intrabony Defect
Sponsored by
Medical University of Warsaw
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring Papilla Preservation Technique, Regenerative Treatment, Allograft, Emdogain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Periodontology and Oral Mucosa Diseases, Medical University of WarsawRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Active Comparator

Arm Label

Experimental: Entire Papilla Preservation Modified Technique (EPPMT)

Entire Papilla Preservation Modified Technique + EMD

EPP Modified Technique+EMD+allograft

EPP Modified Technique+EMD+allograft+sCTG

Arm Description

Procedure: 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.

Procedure: 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.

Procedure: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.

Procedure: 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.

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

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

Full Information

First Posted
July 19, 2021
Last Updated
October 11, 2021
Sponsor
Medical University of Warsaw
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1. Study Identification

Unique Protocol Identification Number
NCT05029089
Brief Title
Modified Entire Papilla Preservation Technique For Treatment Of Intrabony Defects. Clinical Trial.
Acronym
MEPPT
Official Title
Modified Entire Papilla Preservation Technique (MEPPT) For Periodontal Regenerative Treatment Of Intrabony Defects. A Randomized Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 10, 2021 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Warsaw

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Regeneration
Keywords
Papilla Preservation Technique, Regenerative Treatment, Allograft, Emdogain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Entire Papilla Preservation Modified Technique (EPPMT)
Arm Type
Experimental
Arm Description
Procedure: 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.
Arm Title
Entire Papilla Preservation Modified Technique + EMD
Arm Type
Active Comparator
Arm Description
Procedure: 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.
Arm Title
EPP Modified Technique+EMD+allograft
Arm Type
Active Comparator
Arm Description
Procedure: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.
Arm Title
EPP Modified Technique+EMD+allograft+sCTG
Arm Type
Active Comparator
Arm Description
Procedure: 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.
Intervention Type
Procedure
Intervention Name(s)
Modified Entire Papilla Preservation Technique (MEPPT) For Periodontal Regenerative Treatment Of Intrabony Defects.
Intervention Description
Surgical approach using modified papilla preservation technique for regenerative periodontal therapy.
Intervention Type
Device
Intervention Name(s)
Emdogain (EMD), Biomaterials (allograft, subepithelial connective tissue graft/sCTG)
Intervention Description
Surgical approach using modified papilla preservation technique and devices for regenerative periodontal therapy.
Intervention Type
Procedure
Intervention Name(s)
Modified Entire Papilla Preservation Technique (MEPPT) with Emdogain For Periodontal Regenerative Treatment Of Intrabony Defect
Intervention Description
Surgical approach using modified papilla preservation technique and Emdogain for regenerative periodontal therapy.
Intervention Type
Procedure
Intervention Name(s)
Modified Entire Papilla Preservation Technique (MEPPT) with Emdogain and Allograft For Periodontal Regenerative Treatment Of Intrabony Defect
Intervention Description
Surgical approach using modified papilla preservation technique and Emdogain and Allograft for regenerative periodontal therapy.
Intervention Type
Procedure
Intervention Name(s)
Modified Entire Papilla Preservation Technique (MEPPT) with Emdogain and Allograft and sCTG For Periodontal Regenerative Treatment Of Intrabony Defect
Intervention Description
Surgical approach using modified papilla preservation technique and Emdogain and Allograft and sCTG for regenerative periodontal therapy.
Primary Outcome Measure Information:
Title
Periodontal parameters measured before surgery.
Description
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
Time Frame
1-7 days before surgery
Title
Periodontal parameters measured during surgery.
Description
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
Time Frame
During surgery
Title
Periodontal parameters measured on basis of X-ray
Description
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
Time Frame
1-7 days before surgery
Secondary Outcome Measure Information:
Title
Periodontal parameters measured after surgery.
Description
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
Time Frame
12 months after surgery
Other Pre-specified Outcome Measures:
Title
Patient-reported outcomes based on VAS scales
Description
Questionnaires: Scale 1: Pain after surgery (during recent 2 weeks) from 0 (no pain) to 10 (very big pain)
Time Frame
2 weeks after surgery
Title
Patient-reported outcomes based on VAS scales
Description
Scale 2: Eating disturbance (during recent 2 weeks) from 0 (no eating disturbance) to 10 (very big disturbance)
Time Frame
2 weeks after surgery
Title
Patient-reported outcomes based on VAS scales
Description
Scale 3: Daily functioning disturbance (during recent 2 weeks) from 0 (no daily functioning disturbance) to 10 (very big daily functioning disturbance)
Time Frame
2 weeks after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Beata Wyrębek, PhD
Phone
+48692013589
Email
beatawyrebek@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Bartłomiej Górski, PhD
Phone
00 48 22 116 64 31
Email
gorskibartlomiej04@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renata Górska, Professor
Organizational Affiliation
Department of Periodontal and Oral Mucosa Diseases in Warsaw
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw
City
Warsaw
State/Province
Mazowsze
ZIP/Postal Code
00-246
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Batlomiej Gorski, DDS, PhD
Phone
+48 22 502 20 99

12. IPD Sharing Statement

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

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