Buccal Soft Tissue Contour Changes After Immediate Implant Placement With or Without Connective Tissue Graft

Dental Implant Placement Clinical Trial

Official title:

Volumetric Evaluation of Buccal Soft Tissue Contour Using Customized Healing Abutment During Immediate Implant Placement With Connective Tissue Grafting. A Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04309006
• Other study ID #: PER8273003
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: September 1, 2024

Study information

• Verified date: October 2023
• Source: Misr International University
• Contact: Ahmed I Abo El Futtouh, Master
• Phone: +201019999983
• Email: ahmedkey7[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Statement of the problem: Using customized contoured healing abutments at the time of immediate implant placement is a treatment modality to improve esthetics by maintain the soft tissue contour. Using connective tissue grafts enhances and maintains soft tissue stability. However, the effect of the combined procedures for maintenance of the soft tissue morphology remains unclear. Purpose : The aim of the study is to evaluate the volumetric difference of buccal soft tissue contour around immediate implants placed with and without connective tissue grafts and customized healing abutments. Materials and Methods: Fifty-two patients with single maxillary anterior or premolar tooth indicated for extraction will participate in this study, 13 patients will randomly be assigned in each group. Group 1 (test group) will be treated by immediate implant placement (IIP) with connective tissue graft (CTG) and customized healing abutment, Group 2 (test group) IIP with CTG and healing abutment same diameter of the implant, Group 3 (test group) IIP and customized healing abutment, while the 4th group (control) IIP with healing abutment same diameter of the implant. Extra-oral scanning of the buccal contour will be carried out presurgical and at 3, 6, 9 and 12 months after surgery. Difference in contour gained will be compared to the original contour and between groups. Radiographic evaluation will be done using CBCT at 12 months to measure the bone width. In addition, soft tissue thickness, mid facial recession, gingival biotype, interdental papilla height, soft tissue peri- implant parameters and any surgical or prosthetic complications will be assessed.

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. 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 (31). After implant placement, the allocation will be revealed to the practitioner for the type of the healing abutment to be used and whether connective tissue graft will be used or not.

Thirteen implants (intervention 1) will receive screw- retained customized healing abutment, and thirteen other implants in the 2nd intervention group will receive the conventional healing abutment of same diameter of the implant. In both groups connective tissue graft will be used. 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.

The fabrication of the customized healing abutment is as follows; the temporary cylindrical abutment will be screwed to the implant then flowable composite will be injected at the gingival margin level to adapt to the screw-retained temporary cylindrical abutments that will be sand-blasted for mechanical retention of the composite, taking the shape of the socket at the marginal gingiva. 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. Patients will be recalled for regular follow ups. Other thirteen implants (intervention 3) will receive screw- retained customized healing abutment, and for the control (the 4th group) group thirteen implants will receive the conventional healing abutment of same diameter of the implant. No connective tissue grafts are to be used in these two groups.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: September 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Adults at or above the age of 18.

2. Patients who have at least one non-restorable maxillary anterior or premolar tooth with sound adjacent teeth.

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(24).

6. Good oral hygiene

7. Patient accepts to provide an informed consent

Exclusion Criteria:

1. Smokers

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) (25)

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.

Related Conditions & MeSH terms

• Dental Implant Placement

Intervention

Procedure:
• CTG and customized healing abutment
screw- retained customized healing abutment
• CTG and conventional healing abutment
conventional healing abutment

Locations

Country	Name	City	State
Egypt	International Dental Contining Education Centre (IDCE)	Cairo
Egypt	Misr International University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Misr International University

Country where clinical trial is conducted

Egypt, 

References & Publications (39)

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. — View Citation

Amid R, Mirakhori M, Safi Y, Kadkhodazadeh M, Namdari M. Assessment of gingival biotype and facial hard/soft tissue dimensions in the maxillary anterior teeth region using cone beam computed tomography. Arch Oral Biol. 2017 Jul;79:1-6. doi: 10.1016/j.archoralbio.2017.02.021. Epub 2017 Mar 1. — View Citation

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. — View Citation

Borges GJ, Ruiz LF, de Alencar AH, Porto OC, Estrela C. Cone-beam computed tomography as a diagnostic method for determination of gingival thickness and distance between gingival margin and bone crest. ScientificWorldJournal. 2015;2015:142108. doi: 10.1155/2015/142108. Epub 2015 Mar 31. — View Citation

Buser D, Halbritter S, Hart C, Bornstein MM, Grutter L, Chappuis V, Belser UC. Early implant placement with simultaneous guided bone regeneration following single-tooth extraction in the esthetic zone: 12-month results of a prospective study with 20 consecutive patients. J Periodontol. 2009 Jan;80(1):152-62. doi: 10.1902/jop.2009.080360. — View Citation

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. — View Citation

Chen ST, Beagle J, Jensen SS, Chiapasco M, Darby I. Consensus statements and recommended clinical procedures regarding surgical techniques. Int J Oral Maxillofac Implants. 2009;24 Suppl:272-8. No abstract available. — View Citation

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. — View Citation

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. — View Citation

De Bruyckere T, Eghbali A, Younes F, De Bruyn H, Cosyn J. Horizontal stability of connective tissue grafts at the buccal aspect of single implants: a 1-year prospective case series. J Clin Periodontol. 2015 Sep;42(9):876-882. doi: 10.1111/jcpe.12448. Epub 2015 Sep 16. — View Citation

del Castillo RA. Immediate provisionalization of a single-tooth implant with a temporary cylinder in one surgical appointment. Pract Proced Aesthet Dent. 2006 Jun;18(5):suppl 3-5. No abstract available. — View Citation

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. — View Citation

Goodacre CJ, Kan JY, Rungcharassaeng K. Clinical complications of osseointegrated implants. J Prosthet Dent. 1999 May;81(5):537-52. doi: 10.1016/s0022-3913(99)70208-8. — View Citation

Hammerle CH, Chen ST, Wilson TG Jr. Consensus statements and recommended clinical procedures regarding the placement of implants in extraction sockets. Int J Oral Maxillofac Implants. 2004;19 Suppl:26-8. No abstract available. — View Citation

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 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. — View Citation

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. — View Citation

Kan JY, Rungcharassaeng K, Lozada JL, Zimmerman G. Facial gingival tissue stability following immediate placement and provisionalization of maxillary anterior single implants: a 2- to 8-year follow-up. Int J Oral Maxillofac Implants. 2011 Jan-Feb;26(1):179-87. — View Citation

Kan JY, Rungcharassaeng K. Site development for anterior single implant esthetics: the dentulous site. Compend Contin Educ Dent. 2001 Mar;22(3):221-6, 228, 230-1; quiz 232. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Lee CT, Tao CY, Stoupel J. The Effect of Subepithelial Connective Tissue Graft Placement on Esthetic Outcomes After Immediate Implant Placement: Systematic Review. J Periodontol. 2016 Feb;87(2):156-67. doi: 10.1902/jop.2015.150383. Epub 2015 Oct 15. Erratum In: J Periodontol. 2016 Apr;87(4):492. — View Citation

Lemongello GJ Jr. Immediate custom implant provisionalization: a prosthetic technique. Pract Proced Aesthet Dent. 2007 Jun;19(5):273-9. — View Citation

Levine RA, Ganeles J, Kan J, Fava PL. 10 Keys for Successful Esthetic-Zone Single Implants: Importance of Biotype Conversion for Lasting Success. Compend Contin Educ Dent. 2018 Sep;39(8):522-529; quiz 530. — View Citation

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. — View Citation

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. — View Citation

Mihali S. Maintaining Tissue Architecture in Immediate Implant Placement Following Extraction of Natural Teeth Using Custom Healing Screw. Biomed J Sci Tech Res. 2018

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. — View Citation

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. — View Citation

Saito H, Chu SJ, Reynolds MA, Tarnow DP. Provisional Restorations Used in Immediate Implant Placement Provide a Platform to Promote Peri-implant Soft Tissue Healing: A Pilot Study. Int J Periodontics Restorative Dent. 2016 Jan-Feb;36(1):47-52. doi: 10.11607/prd.1945. — View Citation

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. — View Citation

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. — View Citation

Touati B, Guez G, Saadoun A. Aesthetic soft tissue integration and optimized emergence profile: provisionalization and customized impression coping. Pract Periodontics Aesthet Dent. 1999 Apr;11(3):305-14; quiz 316. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 39 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volumetric analysis of buccal contour	Measuring changes in the buccal soft tissue contour in comparison to the original ones, at 2,4 and 6 mm from the pre-operative gingival margin. This will be done using Extra oral scanning and 3D viewer software	Before surgery - 3 months - 6 months - 9 months - 12 months
Secondary	Bucco-palatal width	Measured using Cone Beam CT	Before surgery - 12 months
Secondary	Gingival thickness	Measured using Periodontal Probe	Before surgery - 6 months - 12 months
Secondary	Mid facial recession	Measured with 3D viewer software	Before surgery - 3 months - 6 months - 9 months - 12 months
Secondary	Interdental papillae height	Measured with 3D viewer software	Before surgery - 3 months - 6 months - 9 months - 12 months
Secondary	Modified Plaque Index	Measured with periodontal probe	3 months - 6 months - 9 months - 12 months
Secondary	Modified Bleeding Index	Measured with periodontal probe	3 months - 6 months - 9 months - 12 months
Secondary	Patient satisfaction	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	12 months