Immediate Implants Inserted Through Open Flap, Open Flap and Bone Grafting and Flapless Techniques (ETPEI-RCT)

Evaluation of Morphological and Dimensional Alveolar Bone Changes Around Post-extraction Implants in an Open Flap, Open Flap and Grafting and Flapless Technique. A Clinical Randomized Controlled Study

This is a three-armed randomized controlled clinical trial aiming the estimation of dimensional alveolar bone changes after insertion of post-extraction implants through 3 different surgical techniques: open flap, open flap and grafting, flapless.

Study Overview

• Status: Completed
• Conditions: Isolated Premolar Edentulous Site
• Intervention / Treatment: Device: Open flap immediate implant; Device: Open flap immediate implant and bone grafting; Device: Flapless immediate implant

Detailed Description

Background and Objectives A recent systematic review investigating dimensional alveolar bone changes after insertion of post-extraction implants reported that there is a lack of randomized controlled trials that would serve as a scientific base for building clinical guidelines on alveolar site treatment after insertion of post-extraction implants. Different studies suggest that insertion of post-extraction implants should be performed after fully elevating a flap and inserting bone graft in the residual space between the implant surface and the alveolar socket. Other investigations report insignificant differences between open flap and flapless approaches, whereas the insertion of bone grafts remains controversial.

The present study is a three-armed randomized clinical controlled trial conducted with the following objectives:

1. Evaluation of morphological and alveolar bone level differences (marginal bone loss) on post-extraction implants inserted with the following techniques: 1) open flap surgery alone; 2) open flap surgery and bone grafting; 3) flapless.
2. Estimation of effectiveness of the three surgical techniques through measurement of secondary outcomes such as intra-operatory and post-operatory complications, pain and discomfort, time and costs.

Materials and Methods

• This is a three-armed randomized controlled clinical trial where each arm will belong to one of the treatments: 1) open flap surgery alone; 2) open flap surgery and bone grafting; 3) flapless.
• The randomizing sequence will be generated from a computer program (STATA 13) by a statistician who will also conduct blind statistical analysis of results.
• All patients will be recruited prior to trial commencement. They will be extensively informed regarding the intervention and will sign a treatment consent.
• Patients will be recruited according to the following inclusion criteria: absence of any systemic disease that might compromise implant integration or wound healing, appropriate periodontal health (measured through periodontal indexes), presence of premolars with indications of extractions, presence of adjacent teeth, absence of fenestrations, presence of vestibular alveolar wall with a minimum of 0.5mm of thickness. Patients who have undergone CT scanning in the past 5 years and heavy smokers (more than 20 cigarettes per day) will not be included in the study.
• Calculation of sample size has already been performed by an experienced statistician, accounting for a minimal predicted difference between groups of 1mm (SD 0.75mm) of marginal bone loss, alpha error of 0.05 and 90% of power. Based on these calculations, a total of 45 patients will be included in the study.
• Interventions will be performed in accordance with ethical standards as suggested by the Helsinki Declaration (1975). Approval of Ethical Committee of the University of Bari has already been obtained (reg.nr. 4987).
• All surgical interventions will be performed by the same experienced surgeon who will be informed of the type of intervention after tooth extraction (allocation concealment through dark sealed envelopes).
• The primary outcome is marginal bone loss (MBL) and alveolar bone dimensional changes measured through CT Cone Beam performed immediately after implant insertion and 6 months after. Secondary outcomes are intra-and post-operative complications, pain and discomfort, time and costs.
• Outcomes will be measured by another clinician blinded in terms of treatment allocation.
• Statistical analysis will be performed by an independent statistician. Statistical tests will include: One-way Anova, Bonferroni tests and several linear and logistic regressions in order to estimate potential predictive variables. Statistical significance will be set at .05.
• Interruption of study will be considered in the following situations: 1.preliminary observation of highly significant difference between techniques indicating one technique highly superior; 2. big number of lost to follow-up (bigger than that considered during sample size calculation)
• Patients will be excluded from the study in the following cases: missing follow-up hygiene controls at 1 and 3 months post-intervention, missing 6 months follow-up control, poor cooperation in terms of domestic oral hygiene (periodontal indexes measured), income of systemic or local diseases that might compromise outcomes.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• absence of any systemic disease that might compromise implant integration or wound healing
• appropriate periodontal health (measured through periodontal indexes)
• presence of premolars with indications of extractions, presence of adjacent teeth
• absence of fenestrations
• presence of vestibular alveolar wall with a minimum of 0.5mm of thickness

Exclusion Criteria:

• patients who have undergone CT scanning in the past 5 years
• heavy smokers (more than 20 cigarettes per day)
• patients not showing up at 1 and 3 months hygiene sessions
• patients not showing up at 6 months follow-up

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Open flap immediate implant; Open flap immediate implant insertion, without bone grafting	Device: Open flap immediate implant; Post-extraction implants will be inserted through open flap, without bone grafting; Other Names: Dental implant
Active Comparator: Open flap immediate implant and bone grafting; Open flap immediate implant insertion and bone grafting	Device: Open flap immediate implant and bone grafting; Post-extraction implants will be inserted through open flap, adding bone grafting; Other Names: Dental implant, bone grafting
Active Comparator: Flapless immediate implant; Immediate implant insertion without opening flap of inserting bone grafting	Device: Flapless immediate implant; Post-extraction implants will be inserted without elevating flap or inserting bone grafting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Marginal Bone Loss measured through CT Cone Beam	Difference of marginal bone level measured immediately after treatment and 6 months after on two repeated (immediately after and 6 months after implant insertion) CT Cone Beam	6 months
Alveolar Bone Dimensional Reduction assessed through CT Cone Beam	Three-dimensional Alveolar Bone Reduction (horizontal and vertical) will be measured on two repeated (immediately after and 6 months after implant insertion) on CT Cone Beam, having as reference points the implant platform and the implant apex.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain and Discomfort measured through questionaire	Pain and discomfort experienced by the patient after the surgery, measured through a VAS scale on a questionaire	1 Week
Intra-operatory or post-operatory complications assessed through intra-operatory observation and post-intervention check-ups.	Intra-operatory or post-operatory intervention-related adverse events such as excessive bleeding, swallowing, hematoma will be recorded for each patient.	6 months
Time needed to perform surgical intervention	Time needed to perform surgical intervention (immediately after tooth extraction until finishing of surgical procedure) will be recorded for each intervention.	1-2 hours

Collaborators and Investigators

• Sponsor: University of Bari

Publications and helpful links

General Publications

• Lee CT, Chiu TS, Chuang SK, Tarnow D, Stoupel J. Alterations of the bone dimension following immediate implant placement into extraction socket: systematic review and meta-analysis. J Clin Periodontol. 2014 Sep;41(9):914-26. doi: 10.1111/jcpe.12276. Epub 2014 Jul 23.
• Tarnow DP, Chu SJ. Human histologic verification of osseointegration of an immediate implant placed into a fresh extraction socket with excessive gap distance without primary flap closure, graft, or membrane: a case report. Int J Periodontics Restorative Dent. 2011 Sep-Oct;31(5):515-21.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): November 1, 2018

Study Registration Dates

• First Submitted: December 16, 2016
• First Submitted That Met QC Criteria: December 22, 2016
• First Posted (Estimate): December 23, 2016

Study Record Updates

• Last Update Posted (Actual): January 17, 2019
• Last Update Submitted That Met QC Criteria: January 15, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: bone grafting; immediate dental implant; post-extraction dental implant; open flap; flapless; CT Cone Beam
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Mouth, Edentulous
• Other Study ID Numbers: 4987