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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03007316
Other study ID # 0
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 23, 2017
Est. completion date March 12, 2020

Study information

Verified date November 2020
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date March 12, 2020
Est. primary completion date December 17, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 45 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms

  • Buccal Bone Loss in Immediate Implants

Intervention

Procedure:
VIP graft
surgical soft tissue grafting concomitant to implant placement

Locations

Country Name City State
Egypt Cairo University Cairo Greater Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary "PES" Pink Esthetic Score esthetic assessment by the pink esthetic score introduced by furhauser et al 2005 2 years