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Soft Tissue Volume Changes After Immediate Implants With Two Different Techniques

Primary Purpose

Dental Implant, Tooth Extraction, Bone Resorption

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Dental implant placement after tooth extraction
Sponsored by
Aula Dental Avanzada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Implant focused on measuring Postextraction implant, Implant type 1, Socket-Shield, Soft Tissue volume, RCT

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients requiring single tooth extraction in lateral or anterior areas of the upper jaw.
  • Teeth that do not present alteration or loss of the vestibular bone table.

Exclusion Criteria:

  • Patients in whom surgical intervention is contraindicated.
  • Teeth with alteration or loss of the vestibular bone table.
  • Teeth with marginal recession >2mm.
  • Early or delayed failure of the implant placed with any of the three techniques.

Sites / Locations

  • Clínica Dental EsteveRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Immediate Implant with SST (SST)

Immediate Implant with biomaterial (GAP)

Arm Description

Patients who will receive immediate implant placement using the Socket-Shield Technique.

Patients who will receive immediate implant placement using bone biomaterials to fill the gap after complete extraction of the tooth.

Outcomes

Primary Outcome Measures

Soft tissue volume
Soft tissue volume changes after tooth extraction

Secondary Outcome Measures

Surgery pain perception by Numerical Rating Scale
Pain perception by the patient during surgical procedure, being 0 no pain at all, 1-3 mild discomfort, 4-7 moderate pain and 7-10 intense pain.
Surgery satisfaction of the patient by Numerical Rating Scale
Patients satisfaction after surgery, being 0 not satisfied at all, and 10 very satisfied
General satisfaction of the patient by Numerical Rating Scale
Patients general satisfaction 6 months after the beginning of treatment, being 0 not satisfied at all, and 10 very satisfied
Esthetic satisfaction of the patient by Numerical Rating Scale
Patients esthetic satisfaction 3 months after crown placement, being 0 not satisfied at all, and 10 very satisfied
Function satisfaction of the patient by Numerical Rating Scale
Patients function satisfaction 3 months after crown placement, being 0 not satisfied at all, and 10 very satisfied

Full Information

First Posted
March 13, 2021
Last Updated
January 10, 2023
Sponsor
Aula Dental Avanzada
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1. Study Identification

Unique Protocol Identification Number
NCT04803110
Brief Title
Soft Tissue Volume Changes After Immediate Implants With Two Different Techniques
Official Title
Soft Tissue Volume Changes After Immediate Implants With Two Different Techniques: Randomized Comparative Study.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aula Dental Avanzada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim is to comparatively evaluate the soft tissue volume changes that occur after tooth extraction and immediate dental implant placement using two different surgical techniques. These techniques are: the Socket-Shield technique and conventional immediate placement. The null hypothesis is that the Socket-Shield technique better maintains soft tissue volume after partial tooth extraction and immediate implant placement compared to the conventional technique. From a sample of 30 patients, they will be divided into groups of 10 and will be randomized using the random.org program. The volume of the soft tissues will be recorded by means of a hydrocolloid impression before tooth extraction and 6 months later. The soft tissue dimensional changes produced will be digitally evaluated and statistically analyzed.
Detailed Description
After tooth extraction, the supporting tissues, bone and mucosa will undergo a loss of volume associated with the loss of the cementum-periodontal ligament-bone attachment complex. This alteration in volume can affect aesthetic results, especially when the tooth involves the anterior area, where the alveolar bone is narrower. To compensate for the lost volume loss, some authors promote delayed implant placement, which would facilitate soft tissue management after healing. The conventional immediate implant placement technique proposes the use of bone regeneration biomaterials in the space between the implant wall and the residual vestibular bone. The aim of this technique is to compensate for this bone resorption, thus improving the aesthetic results. In the same sense of compensating for the resorption that will occur, some authors recommend the use of soft tissue grafts in the same operative act of extraction and placement of the immediate implant. Some years ago, some authors presented the technique of partial extraction of the tooth as an alternative to the conventional technique of immediate implant placement after extraction with the aim of avoiding or minimising this resorption. The technique consists of leaving a piece of tooth (shield) inserted in the vestibular alveolar bone area so that the resorption process is slowed down. The presence of bone between the dentine wall of the tooth fragment and the implant has been demonstrated in both animal and ex-vivo histological studies. From a clinical point of view, the Socket-Shield or partial extraction technique has been shown to maintain the vestibular volume in post-extraction implants placed using this technique in both posterior and anterior areas with high aesthetic compromise, maintaining adequate clinical values and patient satisfaction. On the other hand, a 2015 systematic review, comparing immediate and delayed implantation techniques, reports no significant differences between the two, especially at the soft tissue level, although it mentions a lack of quality in the RCTs analysed. A 2017 randomized clinical trial compared the conventional immediate implant placement technique with the delayed or early implantation technique, advising against the former when aesthetics were compromised and limiting it to well-selected cases. In contrast, another more recent randomized clinical trial found no aesthetic, clinical or radiographic differences between the two techniques, and reported similar levels of patient satisfaction. Likewise, a higher rate of early failure has been found in the immediate implantation technique, mentioning the lack of randomised clinical studies comparing both techniques, especially in terms of soft tissue volume changes. A recent randomised clinical study comparing the Socket-Shield technique with the conventional implant placement technique found better levels of marginal bone and pink aesthetic assessment in the former, considering it a safe and feasible technique in the anterior sector. Given the lack of evidence in the literature, there is a palpable need for clinical studies to compare the best technique and/or timing of implant placement after tooth extraction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Implant, Tooth Extraction, Bone Resorption
Keywords
Postextraction implant, Implant type 1, Socket-Shield, Soft Tissue volume, RCT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
10 receiving immediate implant placement with Socket-Shield Technique and 10 receiving immediate implant placement with complete extraction of the tooth. (n=20)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Immediate Implant with SST (SST)
Arm Type
Experimental
Arm Description
Patients who will receive immediate implant placement using the Socket-Shield Technique.
Arm Title
Immediate Implant with biomaterial (GAP)
Arm Type
Active Comparator
Arm Description
Patients who will receive immediate implant placement using bone biomaterials to fill the gap after complete extraction of the tooth.
Intervention Type
Procedure
Intervention Name(s)
Dental implant placement after tooth extraction
Other Intervention Name(s)
Implant surgery
Intervention Description
Immediate implant placement after partial or complete tooth extraction.
Primary Outcome Measure Information:
Title
Soft tissue volume
Description
Soft tissue volume changes after tooth extraction
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Surgery pain perception by Numerical Rating Scale
Description
Pain perception by the patient during surgical procedure, being 0 no pain at all, 1-3 mild discomfort, 4-7 moderate pain and 7-10 intense pain.
Time Frame
Just after surgery
Title
Surgery satisfaction of the patient by Numerical Rating Scale
Description
Patients satisfaction after surgery, being 0 not satisfied at all, and 10 very satisfied
Time Frame
Just after surgery
Title
General satisfaction of the patient by Numerical Rating Scale
Description
Patients general satisfaction 6 months after the beginning of treatment, being 0 not satisfied at all, and 10 very satisfied
Time Frame
6 months after the beginning of treatment
Title
Esthetic satisfaction of the patient by Numerical Rating Scale
Description
Patients esthetic satisfaction 3 months after crown placement, being 0 not satisfied at all, and 10 very satisfied
Time Frame
3 months after after crown placement
Title
Function satisfaction of the patient by Numerical Rating Scale
Description
Patients function satisfaction 3 months after crown placement, being 0 not satisfied at all, and 10 very satisfied
Time Frame
3 months after after crown placement

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients requiring single tooth extraction in lateral or anterior areas of the upper jaw. Teeth that do not present alteration or loss of the vestibular bone table. Exclusion Criteria: Patients in whom surgical intervention is contraindicated. Teeth with alteration or loss of the vestibular bone table. Teeth with marginal recession >2mm. Early or delayed failure of the implant placed with any of the three techniques.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guillem Esteve-Pardo, DDS
Phone
+34 654089109
Email
guillemjoes@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Guillem Esteve-Pardo, DDS
Phone
+34 965215755
Email
clinicaesteve@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillem Esteve-Pardo
Organizational Affiliation
Aula Dental Avanzada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clínica Dental Esteve
City
Alicante
ZIP/Postal Code
03001
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillem Esteve-Pardo, DDS
Phone
+34 654089109
Email
guillemjoes@hotmail.com
First Name & Middle Initial & Last Name & Degree
Guillem Esteve-Pardo, DDS

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share with other researches.
Citations:
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15691354
Citation
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Results Reference
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Results Reference
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Citation
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Results Reference
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Citation
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Results Reference
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Citation
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Results Reference
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Citation
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Results Reference
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Soft Tissue Volume Changes After Immediate Implants With Two Different Techniques

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