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

NCT ID: NCT03007316

Last Updated: 2020-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-23

Study Completion Date

2020-03-12

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Buccal Bone Loss in Immediate Implants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Immediate Implants + VIP graft.

Immediate implants placed with simultaneous vascularized interpositional periosteal (VIP) connective tissue graft augmentation.

Group Type EXPERIMENTAL

VIP graft

Intervention Type PROCEDURE

surgical soft tissue grafting concomitant to implant placement

Immediate Implants only

Immediate Implants only without soft tissue augmentation.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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VIP graft

surgical soft tissue grafting concomitant to implant placement

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Suzy Nabil Naiem

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hani El Nahass, PhD

Role: STUDY_DIRECTOR

Cairo University

Locations

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Cairo University

Cairo, Greater Cairo, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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0

Identifier Type: -

Identifier Source: org_study_id