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Evaluation of Healing of Intra-bony Defects in Modified Minimal Invasive Surgical Technique

Primary Purpose

Periodontal Bone Loss

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
M-MIST
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Bone Loss

Eligibility Criteria

25 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • - Medically free patients attending the outpatient clinic.
  • Both sexes will be included.
  • Age range from 25 - 55.
  • Patients with moderate to advanced chronic periodontitis with pockets ≥ 5 mm 6-8 weeks after phase I (non-surgical) therapy.
  • Vertical 2 or 3 walls Intra-bony defects ≥ 3mm.
  • Perform and maintain good oral hygiene.
  • Able to come for the follow up appointment's needed

Exclusion Criteria:

  • - Smokers.
  • Pregnant patients.
  • Uncooperative patients with poor oral hygiene.
  • Multirooted teeth with furcation involvement.

Sites / Locations

  • Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

M-MIST (group A)

M-MIST (group B)

Arm Description

M-MIST(incomplete granulation tissue removal)

conventional M-MIST.

Outcomes

Primary Outcome Measures

changes in clinical attachment level
It is the distance from the cement-enamel junction to the depth of the pocket.

Secondary Outcome Measures

changes in pocket probing depth
distance from the depth of the pocket to the gingival margin
changes in gingival recession
distance of the exposed root surface from the cemento-enamel junction to the gingival margin
amount of bone fill
difference in bone fill in standardized periapical radiograogh
patient pain and discomfort
by giving the patient a questionnaire to fill
patient satisfaction
by giving the patient a questionnaire to fill

Full Information

First Posted
May 22, 2018
Last Updated
August 25, 2018
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03562039
Brief Title
Evaluation of Healing of Intra-bony Defects in Modified Minimal Invasive Surgical Technique
Official Title
Clinical and Radiographic Evaluation of Intra Bony Defects Following Complete Versus Incomplete Removal of Granulation Tissue in Modified Minimally Invasive Surgical Technique (M-MIST). A Randomized Controlled Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 2019 (Anticipated)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
February 2020 (Anticipated)

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is aiming to compare the clinical and radiographic outcomes after complete versus incomplete removal of granulation tissue during modified minimally invasive surgical technique for management of periodontal intrabony defects in patients with chronic periodontitis.
Detailed Description
Periodontal surgery has been expanding in the world of dentistry throughout the past years, as new techniques are emerging to treat the different and complex periodontal disorders. Surgical procedures in dentistry have undergone major changes to minimize invasiveness. In addition, novel instruments and materials have been made to suit the evolution of the surgical procedures (Cortellini. 2012). Teeth with deep pockets associated with deep intra-bony defects are a clinical challenge for periodontists, where periodontal regeneration has been proven to be effective in managing the treatment of one-, two-, and three-wall intra-bony defects (Needleman and Tucker 2012;Needleman. 2015). Harrel and Rees (1995) were the first to introduce the term minimally invasive surgery (MIS). MIS is used to describe the use of smaller and more precise surgical procedures that are possible by using of magnifying instruments, such as operating microscopes and microsurgical instruments and materials (Cortellini. 2012). The rationale for the development of minimally invasive surgical technique (MIST) includes: reduction of trauma during the surgery, increase in flap and wound stability, improvement of wound primary closure, reduction of surgical time, and minimization of intra-operative and post-operative patient discomfort (Cortellini. 2007). With the use of MIST, Cortellini and Tonneti (2009) confirmed blood clot protection with the aspects of wound and blood clot stability and primary wound closure. An enhancement of MIST, the modified minimally invasive surgical technique (M-MIST), has been introduced by Cortellini in 2009 to further reduce the surgical invasiveness, with three major objectives in mind: (1) minimize the interdental tissue tendency to collapse providing space provision for regeneration, (2) enhance the wound/soft tissue stability and (3) reduce patient morbidity. Some authors evaluated the use of various regenerative material in MIST and M-MIST e.g. Enamel matrix derivative (Cortellini 2007) PDGF-bb (Cosyn et al. 2012) and collagen enriched bovine derived xeno-graft (Mishra et al., 2013). Cortellini (2011) also, noted that the use of regenerative material is not necessary with M-MIST. Hung et al, (2012) reported that granulation tissue could contain progenitor stem cells which are very important components needed for periodontal tissue regeneration. Moreover, Park et al. (2011) assumed that the inflamed granulation tissue could be used to regenerate lost tissues in the same individual in other defective sites according to its regenerative potential. All the previous data raised an important question about the necessity to remove granulation tissues in periodontal regenerative techniques: Is complete removal of granulation tissue in M-MIST is mandate for treating isolated intra-bony defects for better healing?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Bone Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
M-MIST (group A)
Arm Type
Experimental
Arm Description
M-MIST(incomplete granulation tissue removal)
Arm Title
M-MIST (group B)
Arm Type
Active Comparator
Arm Description
conventional M-MIST.
Intervention Type
Procedure
Intervention Name(s)
M-MIST
Intervention Description
minimal invasive surgical technique without thorough removal of granulation tissue
Primary Outcome Measure Information:
Title
changes in clinical attachment level
Description
It is the distance from the cement-enamel junction to the depth of the pocket.
Time Frame
at baseline then 3 , 6 and 9 months
Secondary Outcome Measure Information:
Title
changes in pocket probing depth
Description
distance from the depth of the pocket to the gingival margin
Time Frame
at baseline then at 3,6 and 9 months
Title
changes in gingival recession
Description
distance of the exposed root surface from the cemento-enamel junction to the gingival margin
Time Frame
at baseline then at 3,6 and 9 months
Title
amount of bone fill
Description
difference in bone fill in standardized periapical radiograogh
Time Frame
at baseline then at 6 and 9 months
Title
patient pain and discomfort
Description
by giving the patient a questionnaire to fill
Time Frame
at day of the surgery then at 1 , 3 and 7 days post-surgery
Title
patient satisfaction
Description
by giving the patient a questionnaire to fill
Time Frame
9 months post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - Medically free patients attending the outpatient clinic. Both sexes will be included. Age range from 25 - 55. Patients with moderate to advanced chronic periodontitis with pockets ≥ 5 mm 6-8 weeks after phase I (non-surgical) therapy. Vertical 2 or 3 walls Intra-bony defects ≥ 3mm. Perform and maintain good oral hygiene. Able to come for the follow up appointment's needed Exclusion Criteria: - Smokers. Pregnant patients. Uncooperative patients with poor oral hygiene. Multirooted teeth with furcation involvement.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Ibrahim, BDS
Phone
+201066842084
Email
ah_jb5@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Enjy Ahmed, Ass. prof.
Phone
+201018941119
Email
nourhany08@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hani Nahass, Ass.prof.
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Cairo University
City
Cairo
State/Province
Manyal
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hano Nahass, PhD
Phone
01000252603
Email
nahass77@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
19207892
Citation
Cortellini P, Tonetti MS. Improved wound stability with a modified minimally invasive surgical technique in the regenerative treatment of isolated interdental intrabony defects. J Clin Periodontol. 2009 Feb;36(2):157-63. doi: 10.1111/j.1600-051X.2008.01352.x.
Results Reference
background
PubMed Identifier
1058834
Citation
Ainamo J, Bay I. Problems and proposals for recording gingivitis and plaque. Int Dent J. 1975 Dec;25(4):229-35.
Results Reference
background
PubMed Identifier
19614721
Citation
Fickl S, Thalmair T, Kebschull M, Bohm S, Wachtel H. Microsurgical access flap in conjunction with enamel matrix derivative for the treatment of intra-bony defects: a controlled clinical trial. J Clin Periodontol. 2009 Sep;36(9):784-90. doi: 10.1111/j.1600-051X.2009.01451.x. Epub 2009 Jul 14.
Results Reference
background
PubMed Identifier
5237683
Citation
Ramfjord SP. The Periodontal Disease Index (PDI). J Periodontol. 1967 Nov-Dec;38(6):Suppl:602-10. doi: 10.1902/jop.1967.38.6.602. No abstract available.
Results Reference
background
PubMed Identifier
28820320
Citation
Bajaj P, Agarwal E, Rao NS, Naik SB, Pradeep AR, Kalra N, Priyanka N, Kumari M. Autologous Platelet-Rich Fibrin in the Treatment of 3-Wall Intrabony Defects in Aggressive Periodontitis: A Randomized Controlled Clinical Trial. J Periodontol. 2017 Nov;88(11):1186-1191. doi: 10.1902/jop.2017.120661. Epub 2017 Aug 18.
Results Reference
background
PubMed Identifier
28820322
Citation
Patel GK, Gaekwad SS, Gujjari SK, S C VK. Platelet-Rich Fibrin in Regeneration of Intrabony Defects: A Randomized Controlled Trial. J Periodontol. 2017 Nov;88(11):1192-1199. doi: 10.1902/jop.2017.130710. Epub 2017 Aug 18.
Results Reference
background
Citation
Harrel SK. 1999. "A Minimally Invasive Surgical Approach for Periodontal Regeneration: Surgical Technique and Observations. J Periodontol 70: 1547-1557." Hung, Tzu-yuan, Hsiang-chun Lin, and Ying-jen Chan. 2012. "Isolating Stromal Stem Cells from Periodontal Granulation Tissues," 1171-80. doi:10.1007/s00784-011-0600-5. J-c, Park, Kim J-m, Jung I-h, Kim Jc, Choi S-h, Cho K-s, Kim C-s Isolation, and Chang-sung Kim. 2011. "Isolation and Characterization of Human Periodontal Ligament ( PDL ) Stem Cells ( PDLSCs ) from the Inflamed PDL Tissue : In Vitro and in Vivo Evaluations" 18: 721-31. doi:10.1111/j.1600-051X.2011.01716.x. Lindhe and Nyman, periodontology Clinical. 1985. "Scaling and Granulation Tissue Removal in Periodontal Therapy *," no. 1983: 374-88. Needleman, I. 2015. "Clinical Concepts for Regenerative Therapy in Intrabony Defects" 68: 282-307.
Results Reference
background
PubMed Identifier
21303402
Citation
Cortellini P, Tonetti MS. Clinical and radiographic outcomes of the modified minimally invasive surgical technique with and without regenerative materials: a randomized-controlled trial in intra-bony defects. J Clin Periodontol. 2011 Apr;38(4):365-73. doi: 10.1111/j.1600-051X.2011.01705.x. Epub 2011 Feb 8.
Results Reference
result

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Evaluation of Healing of Intra-bony Defects in Modified Minimal Invasive Surgical Technique

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