Soft and Hard Tissue Changes After Immediate Single-tooth Replacement

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-03

Study Completion Date

2021-06-09

Brief Summary

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A recent systematic review (Lee et al, 2016) reported that placement of a soft tissue graft concurrent with immediate implantation may contribute to the stability of gingival level and the augmentation of soft tissue contour. However, most included studies did not have a control group to directly demonstrate the benefit of an immediate implant combined with soft tissue graft (IMITG) compared to immediate implant alone.The objective of this randomized controlled clinical trial with a parallel design is to evaluate the influence of the connective tissue graft on the buccal bone alterations after tooth extraction and immediate implant placement by means of cone beam computer tomography (CBCT).

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Detailed Description

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All participants will be selected on a consecutive basis, among individuals, above the age of 18 years, referred to Dental Clinic of the San Raffaele University, with a single failing tooth in the upper and lower jaw from second premolar to second premolar, candidates for a single implant restoration. After local anesthesia, a split-full-split thickness envelope flap, as described for the treatment of multiple gingival recessions by Zucchelli and de Sanctis (2000), will be elevated and the tooth will be extracted a-traumatically. The immediate implantation procedure will be carried out according to the manufacture protocol and 1mm of the transmucosal portion of the implant will be positioned under the buccal bone crest. In the group "Implant+CTG" a connective tissue graft (CTG), resulting from the extraoral de-epithelialization with the knife blade of a free gingival graft harvested from the palate, will be anchored at the anatomic papillae with 2 horizontal mattress sutures and positioned 1 mm coronal to the buccal bone crest and in the apical direction 2 mm above the buccal crest. Patients will be followed for 6 months after implant placement and 6 months after loading.

Conditions

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Implant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Implant

Immediate dental implant placement

Group Type ACTIVE_COMPARATOR

Immediate dental implant placement

Intervention Type PROCEDURE

Tooth will be extracted and a dental implant will be positioned at the same time.

Implant+CTG

Immediate dental implant placement with CTG.

Group Type EXPERIMENTAL

Immediate dental implant placement with CTG

Intervention Type PROCEDURE

Tooth will be extracted and a dental implant will be positioned at the same time with a connective tissue graft.

Interventions

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Immediate dental implant placement

Tooth will be extracted and a dental implant will be positioned at the same time.

Intervention Type PROCEDURE

Immediate dental implant placement with CTG

Tooth will be extracted and a dental implant will be positioned at the same time with a connective tissue graft.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* a single tooth to be extracted for endodontic failure, fractures, root caries or resorption in the maxillary and mandibular area from second premolar to second premolar
* patient in good systemic health, with no contraindication for oral surgical interventions

Exclusion Criteria

* patients with impaired systemic diseases that will interfere with surgical interventions (autoimmune diseases, uncontrolled diabetes)
* assumption of bisphosphonate
* smoking more than 10 cigarettes a day

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes