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

NCT04310449 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-11-21

No results posted yet for this study

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

Interventions

PROCEDURE

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.

PROCEDURE

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.

Sponsors & Collaborators

  • Misr International University

    lead OTHER

Principal Investigators

  • Ahmed I Abo El Futtouh, Master · Clinical Director of Implant Program - Misr International University

  • Khaled Abdel-Ghaffar, Professor · Minister of Higher Education and Scientific Research

  • Inas S Hanna, Bsc · Dentist/Researcher - IDCE

  • Nael A Mina, Bsc · Misr International University

  • Abdel Rahman A Abdel Rahman, Master · International Dental Contiuing Education

  • Ahmed F Mostafa, Bsc · International Dental Contiuing Education

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2023-02-01
Completion
2023-02-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04310449 on ClinicalTrials.gov