Soft and Hard Tissue Changes After Immediate Single-tooth... | NCT03784430

Studies
Soft and Hard Tissue Changes After Immediate Single-tooth Replacement

NCT03784430

Sponsor

Università Vita-Salute San Raffaele

Status

Completed

Last Update Posted

May 17, 2022Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Implant

Interventions

Immediate dental implant placement
Immediate dental implant placement with CTG

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 3, 2017Actual

Primary Completion Date

Jun 9, 2021Actual

Completion Date

Jun 9, 2021Actual

First Submitted Date

Dec 19, 2018

First Submission Date that Met QC Criteria

Dec 19, 2018

First Posted Date

Dec 21, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 16, 2022

Last Update Posted Date

May 17, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Massimo de Sanctis, Prof., Università Vita-Salute San RaffaelePrincipal Investigator

Lead Sponsor

Università Vita-Salute San RaffaeleOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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).

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Implant	Active Comparator	Immediate dental implant placement	Procedure: Immediate dental implant placement
Implant+CTG	Experimental	Immediate dental implant placement with CTG.	Procedure: Immediate dental implant placement with CTG

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Immediate dental implant placement	Procedure	Tooth will be extracted and a dental implant will be positioned at the same time.	Implant

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Volumetric buccal bone changes	Ratio scale - lower values represent a better outcome	6 months

Secondary Outcomes

Measure	Description	Time Frame
Volumetric buccal soft tissue changes	Ratio scale - higher values represent a better outcome	6 months
Buccal soft tissue changes	Ratio scale - higher values represent a better outcome

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Massimo de Sanctis, MD	Università Vita-Salute San Raffaele	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Massimo de Sanctis		Milan	Mi	20132	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24593810	Background	Schneider D, Schmidlin PR, Philipp A, Annen BM, Ronay V, Hammerle CH, Attin T, Jung RE. Labial soft tissue volume evaluation of different techniques for ridge preservation after tooth extraction: a randomized controlled clinical trial. J Clin Periodontol. 2014 Jun;41(6):612-7. doi: 10.1111/jcpe.12246. Epub 2014 Mar 26.
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