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

NCT04309006 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2024-10-17

No results posted yet for this study

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

Interventions

PROCEDURE

CTG and customized healing abutment

screw- retained customized healing abutment

PROCEDURE

CTG and conventional healing abutment

conventional 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, Doctor · Minister of Higher Education and Scientific Research

  • Inas M El-Zayat, Doctor · Assoc.Prof - Operative department, Faculty of Dentistry

  • Mariam 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
FACTORIAL

Eligibility

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

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2024-08-01
Completion
2024-08-01

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 NCT04309006 on ClinicalTrials.gov