Soft and Hard Tissue Changes After Immediate Single-tooth Replacement

Soft and Hard Tissue Changes After Immediate Single-tooth Replacement With or Without a Submarginal Connective Tissue Graft

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).

Study Overview

• Status: Completed
• Conditions: Implant
• Intervention / Treatment: Procedure: Immediate dental implant placement; Procedure: Immediate dental implant placement with CTG

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Mi
    • Milan, Mi, Italy, 20132
      • Massimo de Sanctis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Implant; Immediate dental implant placement	Procedure: Immediate dental implant placement; Tooth will be extracted and a dental implant will be positioned at the same time.
Experimental: Implant+CTG; Immediate dental implant placement with CTG.	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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	6 months
Patient perception outcomes	Visual Analogic Scale - values from '0=no pain' to '10=worst pain imaginable'	1 week and 6 months

Collaborators and Investigators

• Sponsor: Università Vita-Salute San Raffaele
• Investigators: Principal Investigator: Massimo de Sanctis, MD, Università Vita-Salute San Raffaele

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2017
• Primary Completion (Actual): June 9, 2021
• Study Completion (Actual): June 9, 2021

Study Registration Dates

• First Submitted: December 19, 2018
• First Submitted That Met QC Criteria: December 19, 2018
• First Posted (Actual): December 21, 2018

Study Record Updates

• Last Update Posted (Actual): May 17, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: Winsix 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No