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Clinical and Radiographic Evaluation of the Entire Papilla Preservation (EPP) Technique Versus Modified Minimally Invasive Surgical Technique (M-MIST) in Treatment of Intraosseous Defects in Patients With Stage III Periodontitis: A Randomized Clinical Trial

Primary Purpose

Intrabony Periodontal Defect

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Entire Papilla Preservation technique
Modified Minimally invasive Surgical Technique
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intrabony Periodontal Defect

Eligibility Criteria

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

Inclusion Criteria:

  • Patients age between 20 and 60 years old.
  • Stage III periodontitis patient having 2 or 3 walled or combined 2 and 3 walled intraosseous defect ≥ 3 mm deep (assessed by trans-gingival probing, radiographic examination) with clinical attachment level (CAL) ≥ 5mm and pocket depth (PD) ≥ 6 mm.
  • Defect not extending to a root furcation area.
  • Vital teeth
  • No history of intake of antibiotics or other medications affecting the periodontium in the previous 6 months.
  • Patients who are cooperative, motivated, and hygiene conscious.

Exclusion Criteria:

  • Any systemic disease that contra-indicates periodontal surgery or may affect healing.
  • Smokers
  • Pregnant females
  • Drug abusers

Sites / Locations

  • Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Entire Papilla Preservation (EPP) technique

Modified Minimally invasive Surgical Technique (M-MIST)

Arm Description

A minimally invasive surgical technique that involves using a vertical incision away from the defect area in order to preserve the integrity of the related interdental papilla and elevating a full thickness flap then using microsurgical instruments to properly debride the intraosseous defect before closing the flap

A minimally invasive surgical technique that involves using a horizontal interdental incision that extends to the buccal aspect of the two teeth adjacent to the intraosseous defect then elevating a full thickness flap then using microsurgical instruments to properly debride the intraosseous defect before closing the flap

Outcomes

Primary Outcome Measures

Clinical attachment Level gain (CAL gain)
CAL gain will be determined by measuring the distance from the cemento-enamel junction to the base of the pocket using a UNC 15 periodontal probe.

Secondary Outcome Measures

Pocket depth (PD)
Probing depth will be measured from the gingival margin to the base of the periodontal pocket using a UNC 15 periodontal probe.
Gingival recession (GR)
Gingival recession will be measured using UNC periodontal probe from the cemento-enamel junction till the gingival margin (Ainamo & Bay, 1975).
Radiographic defect fil
The depth of intra-bony defect (IBD) will be measured from the alveolar bone crest to the base of the defect to detect the amount of bone fill Radiographs will be scanned and the radiographic IBD depth will be measured by a computer-aided software program
Gingival bleeding score
Gingival bleeding score will be performed through gentle probing of the orifice of the gingival crevice from all four surfaces of all teeth using UNC Periodontal probe. Recorded as (+) if bleeding is present or (-) if bleeding is absent. If bleeding occurs within 10 seconds a positive finding is recorded and the number of positive sites is recorded and then expressed as a percentage of the number of sites examined
Post-surgical patient satisfaction
Three questionnaires will be asked to determine patients' satisfaction with the outcome of surgery Considering this was an elective operation, how likely would you be to recommend it to others? If you had to make the decision again, how likely would you be to undergo this surgery'? Considering everything, how satisfied are you with the outcome of your surgery These questions could all be answered by the patient using a 7-point response scale where: Very Satisfied = 7; Not At All Satisfied = 1. (H. A. Kiyak et al., 1984)

Full Information

First Posted
September 21, 2019
Last Updated
February 4, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04100798
Brief Title
Clinical and Radiographic Evaluation of the Entire Papilla Preservation (EPP) Technique Versus Modified Minimally Invasive Surgical Technique (M-MIST) in Treatment of Intraosseous Defects in Patients With Stage III Periodontitis: A Randomized Clinical Trial
Official Title
Clinical and Radiographic Evaluation of the Entire Papilla Preservation (EPP) Technique Versus Modified Minimally Invasive Surgical Technique (M-MIST) in Treatment of Intraosseous Defects in Patients With Stage III Periodontitis: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
February 8, 2020 (Actual)
Primary Completion Date
September 2, 2021 (Actual)
Study Completion Date
November 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Periodontitis is defined as loss of periodontal attachment due to microbial associated host mediated inflammation. This would lead to the apical migration of the junctional epithelium allowing the bacterial biofilm to undergo apical widespread along the root surfaces of teeth causing bone resorption (Tonetti, Greenwell, & Kornman, 2018). The main objective of periodontal surgeries is directed at complete preservation of the interdental soft tissues to achieve primary closure over the intraosseous defected sites during the early phases of wound healing. Evidence shows that surgical techniques are highly predictable in the treatment of pockets associated with deep and shallow intrabony defects affected majorly by the selected flap design. The purpose of the flap design of minimally invasive periodontal surgery is to overcome the drawbacks of conventional periodontal surgeries decreasing the surgical trauma, improving the clot stability, reducing patient discomfort post operatively and minimizing the surgical chair time (Aslan, Buduneli, & Cortellini, 2017b) Modified Minimally Invasive Surgical Technique (M-MIST) is considered one of the latest minimally invasive techniques that have been used in the treatment of intraosseous defects, this technique however entails an incision over the defect-associated interdental papilla that may jeopardize the volume and complex vascular integrity of the interdental tissues, lacking the special flap design that would emphasis clot stability for better wound healing. Where a new surgical technique turned entire papilla preservation has been developed for protection of the wound without affecting the vascularity of the area. (Pierpaolo Cortellini & Tonetti, 2015) This randomized clinical trial compared the clinical and radiographic efficacy of entire papilla preservation surgical technique (EPP) to Modified minimally invasive surgical technique (M-MIST) in the treatment of periodontal intraosseous defects in stage III periodontitis patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intrabony Periodontal Defect

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Entire Papilla Preservation (EPP) technique
Arm Type
Experimental
Arm Description
A minimally invasive surgical technique that involves using a vertical incision away from the defect area in order to preserve the integrity of the related interdental papilla and elevating a full thickness flap then using microsurgical instruments to properly debride the intraosseous defect before closing the flap
Arm Title
Modified Minimally invasive Surgical Technique (M-MIST)
Arm Type
Active Comparator
Arm Description
A minimally invasive surgical technique that involves using a horizontal interdental incision that extends to the buccal aspect of the two teeth adjacent to the intraosseous defect then elevating a full thickness flap then using microsurgical instruments to properly debride the intraosseous defect before closing the flap
Intervention Type
Procedure
Intervention Name(s)
Entire Papilla Preservation technique
Other Intervention Name(s)
EPP
Intervention Description
A minimally invasive technique that allow access to the intrabony defect without affecting the interdental papilla related to it
Intervention Type
Procedure
Intervention Name(s)
Modified Minimally invasive Surgical Technique
Other Intervention Name(s)
M-MIST
Intervention Description
a minimally invasive technique that allow access to the intrabony defect area from the buccal aspect through a horizontal incision below the papilla without elevating it.
Primary Outcome Measure Information:
Title
Clinical attachment Level gain (CAL gain)
Description
CAL gain will be determined by measuring the distance from the cemento-enamel junction to the base of the pocket using a UNC 15 periodontal probe.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Pocket depth (PD)
Description
Probing depth will be measured from the gingival margin to the base of the periodontal pocket using a UNC 15 periodontal probe.
Time Frame
12 months
Title
Gingival recession (GR)
Description
Gingival recession will be measured using UNC periodontal probe from the cemento-enamel junction till the gingival margin (Ainamo & Bay, 1975).
Time Frame
12 months
Title
Radiographic defect fil
Description
The depth of intra-bony defect (IBD) will be measured from the alveolar bone crest to the base of the defect to detect the amount of bone fill Radiographs will be scanned and the radiographic IBD depth will be measured by a computer-aided software program
Time Frame
12 months
Title
Gingival bleeding score
Description
Gingival bleeding score will be performed through gentle probing of the orifice of the gingival crevice from all four surfaces of all teeth using UNC Periodontal probe. Recorded as (+) if bleeding is present or (-) if bleeding is absent. If bleeding occurs within 10 seconds a positive finding is recorded and the number of positive sites is recorded and then expressed as a percentage of the number of sites examined
Time Frame
12 months
Title
Post-surgical patient satisfaction
Description
Three questionnaires will be asked to determine patients' satisfaction with the outcome of surgery Considering this was an elective operation, how likely would you be to recommend it to others? If you had to make the decision again, how likely would you be to undergo this surgery'? Considering everything, how satisfied are you with the outcome of your surgery These questions could all be answered by the patient using a 7-point response scale where: Very Satisfied = 7; Not At All Satisfied = 1. (H. A. Kiyak et al., 1984)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients age between 20 and 60 years old. Stage III periodontitis patient having 2 or 3 walled or combined 2 and 3 walled intraosseous defect ≥ 3 mm deep (assessed by trans-gingival probing, radiographic examination) with clinical attachment level (CAL) ≥ 5mm and pocket depth (PD) ≥ 6 mm. Defect not extending to a root furcation area. Vital teeth No history of intake of antibiotics or other medications affecting the periodontium in the previous 6 months. Patients who are cooperative, motivated, and hygiene conscious. Exclusion Criteria: Any systemic disease that contra-indicates periodontal surgery or may affect healing. Smokers Pregnant females Drug abusers
Facility Information:
Facility Name
Cairo University
City
Cairo
State/Province
Manial
ZIP/Postal Code
00202
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Clinical and Radiographic Evaluation of the Entire Papilla Preservation (EPP) Technique Versus Modified Minimally Invasive Surgical Technique (M-MIST) in Treatment of Intraosseous Defects in Patients With Stage III Periodontitis: A Randomized Clinical Trial

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