- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04310449
Volumetric Changes of Labial Soft Tissue Contour Following Different Approaches With Immediate Implant Placement
Hard and Soft Tissue Alterations on the Use of Dual Zone Concept Versus Connective Tissue Graft at Flapless Maxillary Immediate Implant Placement. A 1-year Randomized Clinical Trial and Volumetric Study.
Study Overview
Status
Conditions
Detailed Description
After administration of local anaesthesia, the tooth will be extracted by the principle investigator without raising flaps, as atraumatically as possible by using periotomes without disturbing the papillary tissues (minimal traumatic extraction technique). After the extraction of the tooth, the socket will be carefully cleaned to excavate the granulation tissue in the marginal and apical regions. The allocation will be revealed to the principle investigator for the 3 implant groups after implant placement.
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ahmed I Abo El Futtouh, Master
- Phone Number: +201019999983
- Email: ahmedkey7@hotmail.com
Study Contact Backup
- Name: Inas M El-Zayat, Doctor
- Phone Number: +201222361579
- Email: inas.elzayat@gmail.com
Study Locations
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Cairo, Egypt
- Misr International University
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Cairo, Egypt
- International Dental Contining Education Centre (IDCE)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients who have at least one non-restorable maxillary anterior or premolar tooth with sound adjacent teeth.
- Adults at or above the age of 18.
- Intact thick biotype gingival tissue with at least 2mm band of keratinized tissue.
- Buccal bone thickness should be 1mm or less assessed in CBCT with good apical bone.
- Sagittal root position type 1 as described by Kan et al(30).
- Good oral hygiene
- Patient accepts to provide an informed consent.
Exclusion Criteria:
- Smokers
- Pregnant and lactating females.
- 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)
- Patients with active infection related at the site of implant/bone graft placement.
- Patients with untreated active periodontal diseases.
- Patients with parafunctional habits
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dual zone concept and customized healing abutment
Immediate implant placement with bone grafts in the dual zone and customized healing abutment.
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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 Names:
|
Active Comparator: Connective tissue graft and customized healing abutment
immediate implant placement with CTG 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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pink Esthetic Score (PES)
Time Frame: 6 months after delivery (18 months after IIP)
|
The PES is based on seven parameters; mesial papilla, distal papilla, soft-tissue level, soft tissue contour, alveolar process deficiency, soft-tissue color, and texture.
The peri-implant mucosa will be evaluated by the seven index points.
The grading using the PES suggested by Fürhauser will be performed.
The contralateral tooth and the adjacent soft tissue served as reference using a 0-1-2 scoring system, with 0 being the lowest and 2 being the highest value (Fürhauser et al., 2005).
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6 months after delivery (18 months after IIP)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Volumetric analysis of buccal contour to assess changes in buccal countour
Time Frame: Before surgery - 3 months - 6 months - 9 months - 12 months
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Measured with Extra oral scanning + 3D viewer software
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Before surgery - 3 months - 6 months - 9 months - 12 months
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Bucco-palatal width
Time Frame: Before surgery - 12 months
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Measured with CBCT
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Before surgery - 12 months
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Gingival thickness
Time Frame: Before surgery - 6 months - 12 months
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Measured with periodontal probe
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Before surgery - 6 months - 12 months
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Mid facial recession to assess the changes in tissue level
Time Frame: Before surgery - 3 months - 6 months - 9 months - 12 months
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Measured with 3D Viewer software
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Before surgery - 3 months - 6 months - 9 months - 12 months
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Interdental papillae height to assess changes in papilla height
Time Frame: Before surgery - 3 months - 6 months - 9 months - 12 months
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Measured with 3D Viewer software
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Before surgery - 3 months - 6 months - 9 months - 12 months
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Modified Plaque Index
Time Frame: 3 months - 6 months - 9 months - 12 months
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Measured with Periodontal probe
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3 months - 6 months - 9 months - 12 months
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Modified Bleeding Index
Time Frame: 3 months - 6 months - 9 months - 12 months
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Measured with Periodontal probe
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3 months - 6 months - 9 months - 12 months
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Patient satisfaction
Time Frame: 12 months
|
Measured with Visual Analogue Scale (VAS).
The patients will mark their satisfaction in a non-numerical 100 mm line ranging from "not at all satisfied=0" (left) to "very satisfied=100" (right), for each implant
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12 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ahmed I Abo El Futtouh, Master, Clinical Director of Implant Program - Misr International University
- Study Chair: Nael A Mina, Bsc, Misr International University
- Study Chair: Abdel Rahman A Abdel Rahman, Master, IDCE
- Study Chair: Ahmed F Mostafa, Bsc, IDCE
- Study Director: Khaled Abdel-Ghaffar, Professor, Minister of Higher Education and Scientific Research
- Study Director: Inas S Hanna, Bsc, Dentist/Researcher - IDCE
Publications and helpful links
General Publications
- Zuhr O, Baumer D, Hurzeler M. The addition of soft tissue replacement grafts in plastic periodontal and implant surgery: critical elements in design and execution. J Clin Periodontol. 2014 Apr;41 Suppl 15:S123-42. doi: 10.1111/jcpe.12185.
- 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.
- 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.
- 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.
- Cosyn J, Eghbali A, Hermans A, Vervaeke S, De Bruyn H, Cleymaet R. A 5-year prospective study on single immediate implants in the aesthetic zone. J Clin Periodontol. 2016 Aug;43(8):702-9. doi: 10.1111/jcpe.12571. Epub 2016 Jun 13.
- Mihali S. Maintaining Tissue Architecture in Immediate Implant Placement Following Extraction of Natural Teeth Using Custom Healing Screw. Biomed J Sci Tech Res. 2018
- 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
- 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.
- van Nimwegen WG, Raghoebar GM, Zuiderveld EG, Jung RE, Meijer HJA, Muhlemann S. Immediate placement and provisionalization of implants in the aesthetic zone with or without a connective tissue graft: A 1-year randomized controlled trial and volumetric study. Clin Oral Implants Res. 2018 Jul;29(7):671-678. doi: 10.1111/clr.13258. Epub 2018 May 27.
- 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, Roe P, Rungcharassaeng K, Patel RD, Waki T, Lozada JL, Zimmerman G. Classification of sagittal root position in relation to the anterior maxillary osseous housing for immediate implant placement: a cone beam computed tomography study. Int J Oral Maxillofac Implants. 2011 Jul-Aug;26(4):873-6.
- Smeets EC, de Jong KJ, Abraham-Inpijn L. Detecting the medically compromised patient in dentistry by means of the medical risk-related history. A survey of 29,424 dental patients in The Netherlands. Prev Med. 1998 Jul-Aug;27(4):530-5. doi: 10.1006/pmed.1998.0285.
- Chrcanovic BR, Kisch J, Albrektsson T, Wennerberg A. Factors Influencing Early Dental Implant Failures. J Dent Res. 2016 Aug;95(9):995-1002. doi: 10.1177/0022034516646098. Epub 2016 May 4.
- Olmedo-Gaya MV, Manzano-Moreno FJ, Canaveral-Cavero E, de Dios Luna-del Castillo J, Vallecillo-Capilla M. Risk factors associated with early implant failure: A 5-year retrospective clinical study. J Prosthet Dent. 2016 Feb;115(2):150-5. doi: 10.1016/j.prosdent.2015.07.020. Epub 2015 Nov 3.
- Vissink A, Spijkervet F, Raghoebar GM. The medically compromised patient: Are dental implants a feasible option? Oral Dis. 2018 Mar;24(1-2):253-260. doi: 10.1111/odi.12762.
- Lobbezoo F, Brouwers JE, Cune MS, Naeije M. Dental implants in patients with bruxing habits. J Oral Rehabil. 2006 Feb;33(2):152-9. doi: 10.1111/j.1365-2842.2006.01542.x.
- Kan JY, Morimoto T, Rungcharassaeng K, Roe P, Smith DH. Gingival biotype assessment in the esthetic zone: visual versus direct measurement. Int J Periodontics Restorative Dent. 2010 Jun;30(3):237-43.
- Testori T, Meltzer A, Del Fabbro M, Zuffetti F, Troiano M, Francetti L, Weinstein RL. Immediate occlusal loading of Osseotite implants in the lower edentulous jaw. A multicenter prospective study. Clin Oral Implants Res. 2004 Jun;15(3):278-84. doi: 10.1111/j.1600-0501.2004.01013.x.
- 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.
- Ueno D, Kobayashi M, Tanaka K, Watanabe T, Nakamura T, Ueda K, Nagano T. Measurement accuracy of alveolar soft tissue contour using a laboratory laser scanner. Odontology. 2018 Apr;106(2):202-207. doi: 10.1007/s10266-017-0315-4. Epub 2017 Aug 2.
- Kim SH, Choi JH, Chung KR, Nelson G. Do sand blasted with large grit and acid etched surface treated mini-implants remain stationary under orthodontic forces? Angle Orthod. 2012 Mar;82(2):304-12. doi: 10.2319/032511-212.1. Epub 2011 Aug 10.
- Koerich L, Weissheimer A, Koerich LE, Luz D, Deeb JG. A Technique of Cone-Beam Computerized Tomography Superimposition in Implant Dentistry. J Oral Implantol. 2018 Oct;44(5):365-369. doi: 10.1563/aaid-joi-D-17-00282. Epub 2018 May 2. No abstract available.
- Cevidanes LH, Styner MA, Proffit WR. Image analysis and superimposition of 3-dimensional cone-beam computed tomography models. Am J Orthod Dentofacial Orthop. 2006 May;129(5):611-8. doi: 10.1016/j.ajodo.2005.12.008.
- Mombelli A, van Oosten MA, Schurch E Jr, Land NP. The microbiota associated with successful or failing osseointegrated titanium implants. Oral Microbiol Immunol. 1987 Dec;2(4):145-51. doi: 10.1111/j.1399-302x.1987.tb00298.x. No abstract available.
- Gluckman H, Salama M, Du Toit J. Partial Extraction Therapies (PET) Part 2: Procedures and Technical Aspects. Int J Periodontics Restorative Dent. 2017 May/Jun;37(3):377-385. doi: 10.11607/prd.3111.
- 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.
- 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, 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.
- Chen ST, Buser D. Clinical and esthetic outcomes of implants placed in postextraction sites. Int J Oral Maxillofac Implants. 2009;24 Suppl:186-217.
- 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.
- 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.
- 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.
- 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.
- Chu SJ, Salama MA, Salama H, Garber DA, Saito H, Sarnachiaro GO, Tarnow DP. The dual-zone therapeutic concept of managing immediate implant placement and provisional restoration in anterior extraction sockets. Compend Contin Educ Dent. 2012 Jul-Aug;33(7):524-32, 534.
- Levin BP, Chu SJ. Changes in Peri-implant Soft Tissue Thickness with Bone Grafting and Dermis Allograft: A Case Series of 15 Consecutive Patients. Int J Periodontics Restorative Dent. 2018 Sep/Oct;38(5):719-727. doi: 10.11607/prd.3561.
- Bhola M, Jacobs L, Kolhatkar S. Immediate implants for aesthetic success: New guidelines. J Int Clin Dent Res Organ. 2016;7(3):138
- Spear FM. The use of implants and ovate pontics in the esthetic zone. Compend Contin Educ Dent. 2008 Mar;29(2):72-4, 76-80; quiz 81, 94.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PER8273002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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