Soft and Hard Tissue Changes After Immediate Single-tooth Replacement

Not Applicable

Completed

• Conditions: Implant
• Interventions: Procedure: Immediate dental implant placement with CTG; Procedure: Immediate dental implant placement

• Registration Number: NCT03784430
• Lead Sponsor: Università Vita-Salute San Raffaele

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.

Study Timeline

• Study Start: 2017-10-03
• Study First Submitted: 2018-12-19
• Study First Submitted QC: 2018-12-19
• Study First Posted: 2018-12-21
• Primary Completion: 2021-06-09
• Study Completion: 2021-06-09
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-16
• Last Update Posted: 2022-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Implant+CTG	Immediate dental implant placement with CTG	Immediate dental implant placement with CTG.
Implant	Immediate dental implant placement	Immediate dental implant placement

Primary Outcome Measures

Name	Time	Method
Volumetric buccal bone changes	6 months	Ratio scale - lower values represent a better outcome

Secondary Outcome Measures

Name	Time	Method
Buccal soft tissue changes	6 months	Ratio scale - higher values represent a better outcome
Patient perception outcomes	1 week and 6 months	Visual Analogic Scale - values from '0=no pain' to '10=worst pain imaginable'
Volumetric buccal soft tissue changes	6 months	Ratio scale - higher values represent a better outcome

Trial Locations

Locations (1)

Massimo de Sanctis; 🇮🇹 Milan, Mi, Italy