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NCT Number: NCT03784430

Soft and Hard Tissue Changes After Immediate Single-tooth Replacement

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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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massimo de Sanctis

Milan, Mi, 20132, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immediate dental implant placement

Procedure

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

Immediate dental implant placement with CTG

Procedure

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

Primary outcomes

  1. Volumetric buccal bone changes

    Time frame: 6 months

    Ratio scale - lower values represent a better outcome

Secondary outcomes

  1. Volumetric buccal soft tissue changes

    Time frame: 6 months

    Ratio scale - higher values represent a better outcome

  2. Buccal soft tissue changes

    Time frame: 6 months

    Ratio scale - higher values represent a better outcome

  3. Patient perception outcomes

    Time frame: 1 week and 6 months

    Visual Analogic Scale - values from '0=no pain' to '10=worst pain imaginable'

Sponsors and collaborators

Lead sponsor

Università Vita-Salute San Raffaele

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Dec 21, 2018
Registry last updated
May 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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