NCT03784430

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 3, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 21, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 9, 2021

Completed
Last Updated

May 17, 2022

Status Verified

May 1, 2022

Enrollment Period

3.7 years

First QC Date

December 19, 2018

Last Update Submit

May 16, 2022

Conditions

Implant

Outcome Measures

Primary Outcomes (1)

  • Volumetric buccal bone changes

    Ratio scale - lower values represent a better outcome

    6 months

Secondary Outcomes (3)

  • Volumetric buccal soft tissue changes

    6 months

  • Buccal soft tissue changes

    6 months

  • Patient perception outcomes

    1 week and 6 months

Study Arms (2)

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

Immediate dental implant placementPROCEDURE

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

Implant
Immediate dental implant placement with CTGPROCEDURE

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

Implant+CTG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massimo de Sanctis

Milan, Mi, 20132, Italy

Location

Related Publications (4)

  • 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.

    PMID: 24593810BACKGROUND

  • Jung RE, Philipp A, Annen BM, Signorelli L, Thoma DS, Hammerle CH, Attin T, Schmidlin P. Radiographic evaluation of different techniques for ridge preservation after tooth extraction: a randomized controlled clinical trial. J Clin Periodontol. 2013 Jan;40(1):90-8. doi: 10.1111/jcpe.12027. Epub 2012 Nov 19.

    PMID: 23163915BACKGROUND

  • Chappuis V, Bornstein MM, Buser D, Belser U. Influence of implant neck design on facial bone crest dimensions in the esthetic zone analyzed by cone beam CT: a comparative study with a 5-to-9-year follow-up. Clin Oral Implants Res. 2016 Sep;27(9):1055-64. doi: 10.1111/clr.12692. Epub 2015 Sep 15.

    PMID: 26370904BACKGROUND

  • Schropp L, Wenzel A, Spin-Neto R, Stavropoulos A. Fate of the buccal bone at implants placed early, delayed, or late after tooth extraction analyzed by cone beam CT: 10-year results from a randomized, controlled, clinical study. Clin Oral Implants Res. 2015 May;26(5):492-500. doi: 10.1111/clr.12424. Epub 2014 Jun 2.

    PMID: 24890861BACKGROUND

Study Officials

  • Massimo de Sanctis, MD

    Università Vita-Salute San Raffaele

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

December 19, 2018

First Posted

December 21, 2018

Study Start

October 3, 2017

Primary Completion

June 9, 2021

Study Completion

June 9, 2021

Last Updated

May 17, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)