Volumetric Changes of Labial Soft Tissue Contour Following Different Approaches with Immediate Implant Placement
NCT ID: NCT04310449
Last Updated: 2024-11-21
Study Results
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Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2020-07-01
2023-02-01
Brief Summary
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Detailed Description
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Group 1: extraction will occur and then followed by immediate implant placement,using standard implant system protocol preparation of the osteotomy will take place. Initial drill will be placed palatally till final drill reached. Placement of the implant without any raising of the flap will be performed in the correct implant position. Primary stability of the implant will be measured by rotational insertion torque value, to be ≥30Ncm (37). Particulate bone grafts are packed in the gap between the implant and the buccal plate of bone and the tissue (dual zone), Followed by customized healing abutment, the temporary cylindrical abutment twill be screwed to the implant and then flowable composite will be injected at the gingival margin level to adapt to the abutment that will be sand-blasted previously for mechanical retention of the composite, taking the shape of the socket at the marginal gingiva, but will only seal the socket without extending deeper apically in the soft tissue. A buccal groove will be made after the polymerization of this material for easier application. The abutments will be removed for final configurations of the apical part mimicking the emergence profile of the extracted tooth and finishing with laboratory discs and burs. The custom healing screw will then be screwed to the implant with the correct torque.
Group 2: Tooth extraction and immediate implant placement as mentioned. Connective tissue grafts will be harvested from the hard palate and placed at the implant sites in a supraperiosteal partial dissection (pouch technique) prepared at the buccal aspect without using vertical incisions and without flap elevation. Sutures will be used to stabilize the graft in its desired place, then will be covered by a customized healing abutment that will be done as mentioned before.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Dual zone concept and customized healing abutment
Immediate implant placement with bone grafts in the dual zone and customized healing abutment.
Dual zone concept and customized healing abutment
Immediate implant placement without flap raising using standard implant system protocol preparation will take place. Followed by bone grafting following dual zone concept and customized healing abutment.
Connective tissue graft and customized healing abutment
immediate implant placement with CTG and customized healing abutment
Connective tissue graft and customized healing abutment
Immediate implant placement without flap raising using standard implant system protocol preparation will take place. Connective tissue grafts from the hard palate will be placed at the implant sites in a supraperiosteal partial dissection prepared at the buccal aspect. Sutures will be used to stabilize the graft, followed by customized healing abutment. Flowable composite will be injected at the gingival margin level to adapt to the sandblasted abutment, taking the shape of the socket at the marginal gingiva. Buccal groove will be made after the polymerization of this material for easier application. The abutments will be removed for final configurations of the apical part mimicking the emergence profile of the extracted tooth and finishing with laboratory discs and burs. The custom healing screw will be screwed to the implant.
Interventions
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Connective tissue graft and customized healing abutment
Immediate implant placement without flap raising using standard implant system protocol preparation will take place. Connective tissue grafts from the hard palate will be placed at the implant sites in a supraperiosteal partial dissection prepared at the buccal aspect. Sutures will be used to stabilize the graft, followed by customized healing abutment. Flowable composite will be injected at the gingival margin level to adapt to the sandblasted abutment, taking the shape of the socket at the marginal gingiva. Buccal groove will be made after the polymerization of this material for easier application. The abutments will be removed for final configurations of the apical part mimicking the emergence profile of the extracted tooth and finishing with laboratory discs and burs. The custom healing screw will be screwed to the implant.
Dual zone concept and customized healing abutment
Immediate implant placement without flap raising using standard implant system protocol preparation will take place. Followed by bone grafting following dual zone concept and customized healing abutment.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Adults at or above the age of 18.
3. Intact thick biotype gingival tissue with at least 2mm band of keratinized tissue.
4. Buccal bone thickness should be 1mm or less assessed in CBCT with good apical bone.
5. Sagittal root position type 1 as described by Kan et al(30).
6. Good oral hygiene
7. Patient accepts to provide an informed consent.
Exclusion Criteria
2. Pregnant and lactating females.
3. Medically compromised patients. , as Uncontrolled diabetic patients, patients taking bisphosphonates injection for treatment of osteoporosis, patients with active cardiac diseases, patients undergoing radiotherapy or chemotherapy, or any other medical and general contraindications for the surgical procedure (i.e. ASA score ≥III) (31)
4. Patients with active infection related at the site of implant/bone graft placement.
5. Patients with untreated active periodontal diseases.
6. Patients with parafunctional habits
18 Years
50 Years
ALL
Yes
Sponsors
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Misr International University
OTHER
Responsible Party
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Ahmed Abo El Futtouh
Clinical Director of Implant Program - Periodontology and Implantology Consultant
Principal Investigators
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Ahmed I Abo El Futtouh, Master
Role: PRINCIPAL_INVESTIGATOR
Clinical Director of Implant Program - Misr International University
Khaled Abdel-Ghaffar, Professor
Role: STUDY_DIRECTOR
Minister of Higher Education and Scientific Research
Inas S Hanna, Bsc
Role: STUDY_DIRECTOR
Dentist/Researcher - IDCE
Nael A Mina, Bsc
Role: STUDY_CHAIR
Misr International University
Abdel Rahman A Abdel Rahman, Master
Role: STUDY_CHAIR
International Dental Contiuing Education
Ahmed F Mostafa, Bsc
Role: STUDY_CHAIR
International Dental Contiuing Education
Locations
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International Dental Contining Education Centre (IDCE)
Cairo, , Egypt
Misr International University
Cairo, , Egypt
Countries
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References
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Fuentealba R, Jofre J. Esthetic failure in implant dentistry. Dent Clin North Am. 2015 Jan;59(1):227-46. doi: 10.1016/j.cden.2014.08.006. Epub 2014 Sep 26.
Esposito M, Grusovin MG, Felice P, Karatzopoulos G, Worthington HV, Coulthard P. The efficacy of horizontal and vertical bone augmentation procedures for dental implants - a Cochrane systematic review. Eur J Oral Implantol. 2009 Autumn;2(3):167-84.
Chen ST, Buser D. Esthetic outcomes following immediate and early implant placement in the anterior maxilla--a systematic review. Int J Oral Maxillofac Implants. 2014;29 Suppl:186-215. doi: 10.11607/jomi.2014suppl.g3.3.
Buser D, Martin W, Belser UC. Optimizing esthetics for implant restorations in the anterior maxilla: anatomic and surgical considerations. Int J Oral Maxillofac Implants. 2004;19 Suppl:43-61.
Grunder U, Gracis S, Capelli M. Influence of the 3-D bone-to-implant relationship on esthetics. Int J Periodontics Restorative Dent. 2005 Apr;25(2):113-9.
Araujo MG, Lindhe J. Dimensional ridge alterations following tooth extraction. An experimental study in the dog. J Clin Periodontol. 2005 Feb;32(2):212-8. doi: 10.1111/j.1600-051X.2005.00642.x.
Araujo MG, Sukekava F, Wennstrom JL, Lindhe J. Tissue modeling following implant placement in fresh extraction sockets. Clin Oral Implants Res. 2006 Dec;17(6):615-24. doi: 10.1111/j.1600-0501.2006.01317.x.
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Horvath A, Mardas N, Mezzomo LA, Needleman IG, Donos N. Alveolar ridge preservation. A systematic review. Clin Oral Investig. 2013 Mar;17(2):341-63. doi: 10.1007/s00784-012-0758-5. Epub 2012 Jul 20.
Masaki C, Nakamoto T, Mukaibo T, Kondo Y, Hosokawa R. Strategies for alveolar ridge reconstruction and preservation for implant therapy. J Prosthodont Res. 2015 Oct;59(4):220-8. doi: 10.1016/j.jpor.2015.04.005. Epub 2015 May 26.
De Risi V, Clementini M, Vittorini G, Mannocci A, De Sanctis M. Alveolar ridge preservation techniques: a systematic review and meta-analysis of histological and histomorphometrical data. Clin Oral Implants Res. 2015 Jan;26(1):50-68. doi: 10.1111/clr.12288. Epub 2013 Nov 1.
Luckerath W, Roder L, Enkling N. The Effect of Primary Stabilization of the Graft in a Combined Surgical and Prosthodontic Ridge Preservation Protocol: A Prospective Controlled Clinical Pilot Study. Int J Periodontics Restorative Dent. 2018 May/Jun;38(3):e49-e58. doi: 10.11607/prd.3172.
Kan JY, Rungcharassaeng K. Immediate placement and provisionalization of maxillary anterior single implants: a surgical and prosthodontic rationale. Pract Periodontics Aesthet Dent. 2000 Nov-Dec;12(9):817-24; quiz 826.
Kan JYK, Rungcharassaeng K, Deflorian M, Weinstein T, Wang HL, Testori T. Immediate implant placement and provisionalization of maxillary anterior single implants. Periodontol 2000. 2018 Jun;77(1):197-212. doi: 10.1111/prd.12212. Epub 2018 Feb 25.
Tarnow DP, Chu SJ, Salama MA, Stappert CF, Salama H, Garber DA, Sarnachiaro GO, Sarnachiaro E, Gotta SL, Saito H. Flapless postextraction socket implant placement in the esthetic zone: part 1. The effect of bone grafting and/or provisional restoration on facial-palatal ridge dimensional change-a retrospective cohort study. Int J Periodontics Restorative Dent. 2014 May-Jun;34(3):323-31. doi: 10.11607/prd.1821.
Chu SJ, Salama MA, Garber DA, Salama H, Sarnachiaro GO, Sarnachiaro E, Gotta SL, Reynolds MA, Saito H, Tarnow DP. Flapless Postextraction Socket Implant Placement, Part 2: The Effects of Bone Grafting and Provisional Restoration on Peri-implant Soft Tissue Height and Thickness- A Retrospective Study. Int J Periodontics Restorative Dent. 2015 Nov-Dec;35(6):803-9. doi: 10.11607/prd.2178.
Chu SJ, Saito H, Salama MA, Garber DA, Salama H, Sarnachiaro GO, Reynolds MA, Tarnow DP. Flapless Postextraction Socket Implant Placement, Part 3: The Effects of Bone Grafting and Provisional Restoration on Soft Tissue Color Change-A Retrospective Pilot Study. Int J Periodontics Restorative Dent. 2018 Jul/Aug;38(4):509-516. doi: 10.11607/prd.3571.
Akin R. A New Concept in Maintaining the Emergence Profile in Immediate Posterior Implant Placement: The Anatomic Harmony Abutment. J Oral Maxillofac Surg. 2016 Dec;74(12):2385-2392. doi: 10.1016/j.joms.2016.06.184. Epub 2016 Jul 1.
Janakievski J. Case Report : Maintenance of Gingival Form Following Immediate Implant Placement - The Custom-Healing Abutment. Adv Esthet Interdiscip Dent. 2007;3(4):4-7
Mihali S. Maintaining Tissue Architecture in Immediate Implant Placement Following Extraction of Natural Teeth Using Custom Healing Screw. Biomed J Sci Tech Res. 2018
Zuiderveld EG, Meijer HJA, den Hartog L, Vissink A, Raghoebar GM. Effect of connective tissue grafting on peri-implant tissue in single immediate implant sites: A RCT. J Clin Periodontol. 2018 Feb;45(2):253-264. doi: 10.1111/jcpe.12820. Epub 2017 Dec 5.
Kan JY, Rungcharassaeng K, Morimoto T, Lozada J. Facial gingival tissue stability after connective tissue graft with single immediate tooth replacement in the esthetic zone: consecutive case report. J Oral Maxillofac Surg. 2009 Nov;67(11 Suppl):40-8. doi: 10.1016/j.joms.2009.07.004.
Kolerman R, Nissan J, Mijiritsky E, Hamoudi N, Mangano C, Tal H. Esthetic assessment of immediately restored implants combined with GBR and free connective tissue graft. Clin Oral Implants Res. 2016 Nov;27(11):1414-1422. doi: 10.1111/clr.12755. Epub 2016 Jan 7.
Other Identifiers
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PER8273002
Identifier Type: -
Identifier Source: org_study_id
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