Evaluation of Healing of Intra-bony Defects in Modified Minimal Invasive Surgical Technique
NCT ID: NCT03562039
Last Updated: 2024-03-05
Study Results
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Basic Information
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COMPLETED
NA
16 participants
INTERVENTIONAL
2018-04-15
2021-04-03
Brief Summary
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Detailed Description
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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?
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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M-MIST (group A)
M-MIST(incomplete granulation tissue removal)
M-MIST
minimal invasive surgical technique without thorough removal of granulation tissue
M-MIST (group B)
conventional M-MIST.
M-MIST
minimal invasive surgical technique without thorough removal of granulation tissue
Interventions
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M-MIST
minimal invasive surgical technique without thorough removal of granulation tissue
Eligibility Criteria
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Inclusion Criteria
* 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.
* Perform and maintain good oral hygiene.
* Able to come for the follow up appointment's needed
Exclusion Criteria
* Pregnant patients.
* patients with poor oral hygiene.
* Multirooted teeth with furcation involvement.
25 Years
55 Years
ALL
Yes
Sponsors
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Cairo University
OTHER
Responsible Party
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Ahmed Ibrahim
principle investigator
Principal Investigators
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Hani Nahass, Ass.prof.
Role: STUDY_DIRECTOR
Cairo University
Locations
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Cairo University
Cairo, Manyal, Egypt
Cairo University
Giza, , Egypt
Countries
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References
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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.
Ainamo J, Bay I. Problems and proposals for recording gingivitis and plaque. Int Dent J. 1975 Dec;25(4):229-35.
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.
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.
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.
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.
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.
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.
Other Identifiers
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125896
Identifier Type: -
Identifier Source: org_study_id
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