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

NCT04309006 | Completed

• 1 other identifier: PER8273003
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Dental Implant Placement

Keywords

Immediate implant placement; Connective tissue graft; buccal soft tissue contour; customized healing abutment; volumetric analysis; cone beam computerized tomography (CBCT)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Bucco-palatal width

  Before surgery - 12 months

• Gingival thickness

  Before surgery - 6 months - 12 months

• Mid facial recession

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

• Interdental papillae height

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

• Modified Plaque Index

  3 months - 6 months - 9 months - 12 months

Study Arms (4)

CTG and customized healing abutment

EXPERIMENTAL

Customized healing abutment used with connective tissue graft

Procedure: CTG and customized healing abutment

CTG and conventional healing abutment

EXPERIMENTAL

Conventional healing abutment (same diameter of the implant) used with connective tissue graft

Procedure: CTG and conventional healing abutment

customized healing abutment

ACTIVE COMPARATOR

Customized healing abutment used without connective tissue graft

Procedure: CTG and customized healing abutment

conventional healing abutment

ACTIVE COMPARATOR

Conventional healing abutment (same diameter of the implant) without connective tissue graft

Procedure: CTG and conventional healing abutment

Interventions

CTG and customized healing abutment PROCEDURE

screw- retained customized healing abutment

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

CTG and customized healing abutment; customized healing abutment

CTG and conventional healing abutment PROCEDURE

conventional healing abutment

Also known as: Zimmer biomed dental implants and connective tissue graft

CTG and conventional healing abutment; conventional healing abutment

Eligibility Criteria

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

You may qualify if:

• Adults at or above the age of 18.
• Patients who have at least one non-restorable maxillary anterior or premolar tooth with sound adjacent teeth.
• 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(24).
• 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) (25)
• 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 (39)

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Study Officials

• Ahmed I Abo El Futtouh, Master

  Clinical Director of Implant Program - Misr International University

  PRINCIPAL INVESTIGATOR

• Khaled Abdel-Ghaffar, Doctor

  Minister of Higher Education and Scientific Research

  STUDY DIRECTOR

• Inas M El-Zayat, Doctor

  Assoc.Prof - Operative department, Faculty of Dentistry

  STUDY DIRECTOR

• Mariam 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: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Director of Implant Program - Periodontology and Implantology Consultant

Model Details: The first factor is the use of connective tissue graft which includes two levels and the second factor is the use of healing abutment which includes two levels.

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: March 16, 2020
• Study Start: July 1, 2020
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: October 17, 2024

Record last verified: 2024-10

Data Sharing

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

Locations

EG (2)