Volumetric Changes of Labial Soft Tissue Contour Following Different Approaches with Immediate Implant Placement

NCT04310449 | Completed

• 1 other identifier: PER8273002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

Statement of the problem: Tooth extraction is followed by ridge alteration and soft tissue contour collapse. Different strategies were proposed to limit this collapse however, the ability of these techniques to mimic the original soft tissue contour and to maintain long term stability is unclear. Purpose : The aim of this study is to evaluate the volumetric difference of buccal soft tissue contour as well as the radiographic changes, following tooth extraction and immediate implant placement with dual zone concept versus connective tissue graft. Materials and Methods: Thirty patients with single maxillary anterior or premolar tooth indicated for extraction will participate in this study, 15 patient in each group. Group 1 (test group) will be treated by immediate implant placement (IIP) with particulate bone grafts in the dual zone (the bone zone and the tissue zone) and customized healing abutment. Group 2 (control group) IIP with connective tissue graft (CTG) and customized healing abutment. Patient allocation is random for the 2 groups. Data will be collected pre-surgically and at follow up periods (3,6,9\&12 months and 6 months after delivery). Extra-oral scanning of the labial contour will be carried out to evaluate difference in contour gained and will be compared to the original contour and between treatment groups. Radiographic evaluation will be done using CBCT pre-operatively and at 12 months.

Conditions

Dental Implant Placement

Keywords

Immediate implant placement; Connective tissue graft; dual-zone therapeutic concept; customized healing abutment; buccal soft tissue contour; volumetric analysis

Outcome Measures

Primary Outcomes (1)

• Pink Esthetic Score (PES)

  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).

  6 months after delivery (18 months after IIP)

Secondary Outcomes (8)

• Bucco-palatal width

  Before surgery - 12 months

• Gingival thickness

  Before surgery - 6 months - 12 months

• Mid facial recession to assess the changes in tissue level

  Before surgery - 3 months - 6 months - 9 months - 12 months

• Interdental papillae height to assess changes in papilla height

  Before surgery - 3 months - 6 months - 9 months - 12 months

• Modified Plaque Index

  3 months - 6 months - 9 months - 12 months

Study Arms (2)

Dual zone concept and customized healing abutment

EXPERIMENTAL

Immediate implant placement with bone grafts in the dual zone and customized healing abutment.

Procedure: Dual zone concept and customized healing abutment

Connective tissue graft and customized healing abutment

ACTIVE COMPARATOR

immediate implant placement with CTG and customized healing abutment

Procedure: Connective tissue graft and customized healing abutment

Interventions

Connective tissue graft and customized healing abutment PROCEDURE

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.

Also known as: zimmer biomed dental implants and connective tissue grafts and customized healing abutments

Connective tissue graft and customized healing abutment

Dual zone concept and customized healing abutment PROCEDURE

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.

Also known as: zimmer biomed dental implants and dual zone bone grafting and customized healing abutments

Dual zone concept and customized healing abutment

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Misr International University: lead

Study Sites (2)

International Dental Contining Education Centre (IDCE)

Cairo, Egypt

Location

Misr International University

Cairo, Egypt

Location

Related Publications (24)

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  PMID: 27007188 BACKGROUND

• 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.

  PMID: 29641631 BACKGROUND

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  PMID: 11405020 BACKGROUND

• 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.

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• 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.

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• 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.

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  BACKGROUND

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

  BACKGROUND

• 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.

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• 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.

  PMID: 19835749 BACKGROUND

• 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.

  PMID: 26743894 BACKGROUND

Study Officials

• Ahmed I Abo El Futtouh, Master

  Clinical Director of Implant Program - Misr International University

  PRINCIPAL INVESTIGATOR

• Khaled Abdel-Ghaffar, Professor

  Minister of Higher Education and Scientific Research

  STUDY DIRECTOR

• Inas S Hanna, Bsc

  Dentist/Researcher - IDCE

  STUDY DIRECTOR

• Nael A Mina, Bsc

  Misr International University

  STUDY CHAIR

• Abdel Rahman A Abdel Rahman, Master

  International Dental Contiuing Education

  STUDY CHAIR

• Ahmed F Mostafa, Bsc

  International Dental Contiuing Education

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Director of Implant Program - Periodontology and Implantology Consultant

Model Details: • To compare the volumetric changes in the buccal soft tissue contour between immediate implants with CTG and customized healing abutments, and immediate implants with bone grafting in the dual zone and customized healing abutmnets

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: March 17, 2020
• Study Start: July 1, 2020
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR
• Time Frame: One year
• Access Criteria: Principal investigator

Locations

EG (2)