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Completed

NCT Number: NCT03007316

Evaluation of Esthetics Around Immediate Implants in VIP - CT Grafted vs Non-grafted Sites.RCT

An array of soft tissue augmentation techniques have been employed concomitant to implant placement, as free connective tissue grafts or pedicle grafts for keratinized tissue thickening in attempt not only to augment the soft tissue for better resistance to inflammation and improved esthetic stability, but to preserve buccal bone thickness as well.

Results obtained from the literature were controversial regarding the need of soft tissue augmentation to curb buccal bone resorption and preserve pink esthetics. Scarce literature was found, that monitored the ridge alterations following implant placement.

Our study will monitor the effect of soft tissue augmentation on soft tissue esthetics and buccal bone resorption during the process of remodeling in a measurable way.

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Key information

Conditions

Buccal Bone Loss in Immediate Implants

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, Greater Cairo, 12613, Egypt

About this study

Alveolar bone remodeling following extraction could not be prevented by immediate implant placement. Soft tissue augmentaion techniques have been suggested in order to overcome the alterations of buccal bone during remodeling. Nevertheless, it is still inconclusive whether soft tissue augmentation procedures actually have a protective role in preserving buccal bone thickness in immediate implants.

Aim is to clinically and radiographically assess the effect of soft tissue grafting on buccal bone resorption and pink esthetics around immediately placed implants in maxillary anterior teeth after 24 months following implant placement. 18 non-restorable maxillary anterior teeth randomly assigned into 2 groups: (test group) immediately placed implants with simultaneous vascular interpositional periosteal connective tissue (VIP-CT) grafting versus non-augmented implant sites (control group). Buccal bone changes were assessed at implant placement (0) and at 4,9,12 and 24 months from baseline by specially manufactured device and at 24 months by cone beam computed tomography scans (CBCT). Pink esthetic score (PES) was evaluated at 6, 9, 12 and 24 months intervals. Pain and satisfaction were assessed through questionnaires to the patients.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who have at least one unrestorable tooth in the esthetic zone that needs to be extracted.
  • Patients with healthy systemic condition.
  • Buccal bone thickness should be at least 1mm.
  • Availability of bone apical and palatal to the socket to provide primary stability.
  • Good oral hygiene.

Exclusion criteria

  • Patients with signs of acute infection related to the area of interest.
  • Current and former smokers
  • Pregnant.

Treatment and study plan

VIP graft

Procedure

surgical soft tissue grafting concomitant to implant placement

Primary outcomes

  1. "PES" Pink Esthetic Score

    Time frame: 2 years

    esthetic assessment by the pink esthetic score introduced by furhauser et al 2005

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Clinical Evaluation of Soft Tissue Esthetics Around Immediate Implants in Vascularized Interpositional Periosteal Connective Tissue Grafted Versus Non-grafted Sites. A Randomized Controlled Clinical Trial.

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Jan 2, 2017
Registry last updated
Nov 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.