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

NCT03562039 | Completed

• 1 other identifier: 125896
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

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.

Conditions

Periodontal Regeneration, Clinical and Radiographic Results, Modified Minimal Invasive Surgery

Outcome Measures

Primary Outcomes (1)

• changes in clinical attachment level

  It is the distance from the cement-enamel junction to the depth of the pocket.

  at baseline then 6, 9 and 12 months

Secondary Outcomes (5)

• changes in pocket probing depth

  at baseline then at 6, 9 and 12 months

• changes in gingival recession

  at baseline then at 6, 9 and 12 months

• amount of bone fill

  at baseline then at 6, 9 and 12 months

• patient pain and discomfort

  at day of the surgery then at 1 , 3 and 7 days post-surgery

• patient satisfaction

  12 months post-surgery

Study Arms (2)

M-MIST (group A)

EXPERIMENTAL

M-MIST(incomplete granulation tissue removal)

Procedure: M-MIST

M-MIST (group B)

ACTIVE COMPARATOR

conventional M-MIST.

Procedure: M-MIST

Interventions

M-MIST PROCEDURE

minimal invasive surgical technique without thorough removal of granulation tissue

M-MIST (group A); M-MIST (group B)

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- systemically healthy patients
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (2)

Cairo University

Cairo, Manyal, Egypt

Location

Cairo University

Giza, 12588, Egypt

Location

Related Publications (8)

• 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.

  PMID: 19207892 BACKGROUND

• Ainamo J, Bay I. Problems and proposals for recording gingivitis and plaque. Int Dent J. 1975 Dec;25(4):229-35.

  PMID: 1058834 BACKGROUND

• 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.

  PMID: 19614721 BACKGROUND

• 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.

  PMID: 5237683 BACKGROUND

• 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.

  PMID: 28820320 BACKGROUND

• 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.

  PMID: 28820322 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 21303402 RESULT

Study Officials

• Hani Nahass, Ass.prof.

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: June 19, 2018
• Study Start: April 15, 2018
• Primary Completion: March 30, 2021
• Study Completion: April 3, 2021
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

EG (2)