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Implant Abutment Dis-/Reconnection and Peri-Implant Marginal Bone Loss.

Primary Purpose

Alveolar Bone Loss

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Implant surgery
Three abutment dis-/reconnections.
No abutment dis-/reconnections.
Sponsored by
Fortaleza University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alveolar Bone Loss focused on measuring dental implant, bone preservation, definitive abutment, one abutment one time

Eligibility Criteria

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

Inclusion Criteria:

  • Partially edentulous patients requiring dental implant treatment for one or two dental units;
  • Occlusal stability and regular occlusal plane;
  • Enough space for implant and prosthesis;
  • Good periodontal health
  • Keratinized mucosa width > 4mm;
  • Implant primary stability > 65 ISQ and insertion torque > 20Ncm;

Exclusion Criteria:

  • Diabetes mellitus;
  • Treatment with bisphosphonates;
  • Head and neck irradiation;
  • General contraindications to oral surgery;
  • Pregnancy;
  • Bone graft;
  • Bruxism;
  • Smoking habits.

Sites / Locations

  • Fortaleza University; Health Sciences Center; School of Dentistry.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Definitive abutment

Conventional treatment

Arm Description

Implant surgery. No abutment dis-/reconnections.

Implant surgery. Three abutment dis-/reconnections.

Outcomes

Primary Outcome Measures

Peri-implant marginal bone level change.
To estimate the gingival margin stability and the long-term success of implant-supported restorations, the peri-implant marginal bone level will be assessed as primary outcome through intraoral radiographs, in a perspective of bone maintenance, bone loss or bone gain.

Secondary Outcome Measures

Implant stability change.
The implant stability will be measured using a resonance frequency analysis equipment to confirm the implant osseointegration.
Gingival level change.
The gingival level will be measured using a periodontal probe and an acrylic stent as a reference.
Peri-implant probing depth change.
To evaluate the peri-implant health, the probing depth will be assessed in 6 areas around the implant using the prosthetic abutment as a reference.
Bleeding on probing change.
To evaluate the peri-implant health, the bleeding on probing will be observer or not at until 10 seconds after peri-implant probing.

Full Information

First Posted
November 19, 2015
Last Updated
August 7, 2018
Sponsor
Fortaleza University
Collaborators
Universidade Federal do Ceara
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1. Study Identification

Unique Protocol Identification Number
NCT02617212
Brief Title
Implant Abutment Dis-/Reconnection and Peri-Implant Marginal Bone Loss.
Official Title
Impact of Implant Abutment Dis-/Reconnection on Peri-Implant Marginal Bone Loss - Randomized Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
November 1, 2015 (Actual)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fortaleza University
Collaborators
Universidade Federal do Ceara

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to investigate whether the immediate definitive abutment connection to dental implant is effective in preventing marginal bone loss when compared to the conventional treatment with late abutment/implant connection, which include three disconnections and reconnections.
Detailed Description
The proposed study is a randomized clinical trial in which the participants will be allocated into one of the two arms according to the proposed intervention: experimental group, in which the abutments will be permanently connected immediately at the implant placement procedure; and control group (active comparator) with conventional treatment, where the abutments will be disconnected and reconnected three times. Considering the inclusion and exclusion criteria related to oral and systemic health, a sample of participants will be selected among those partially edentulous patients who seek for dental implants treatment at the Fortaleza University School of Dentistry. The sample size has been calculated based on the standard deviation of 0.17 mm, significance level of 5% and 80% statistical test power. To detect a clinically significant difference of 0.2 mm, each group should be composed of 11 participants. Therefore, considering a 10% margin for possible dropouts or missing data, the study will include 24 participants divided into two groups. Each participant will receive one or two implants according to his/her needs, so the study may include more than 24 implants. A single surgeon will perform the implant surgical procedure in order to reduce variations inherent to clinical experience. After local anesthesia and incision on the top of the alveolar ridge, the bone will be exposed by the mucoperiosteal flap elevation. The mucosal thickness will be measured at implant sites, before the lingual/palatal flap elevation, with a periodontal probe. The drilling sequence will be done according to manufacturer's recommendations, under saline solution irrigation, intermittent movements and speed up to 1200rpm. The implants should develop a final insertion torque of 32Ncm or above to enable abutment connection torque, indicated at the experimental arm. The implant primary stability will be also measured by resonance frequency analysis (Osstell; Osstell AB, Gothenburg, Sweden). A minimum 65 ISQ will be required to a single-stage surgery. Thus, those implants that do not contemplate these requirements will be excluded from the study and will receive a conventional treatment with two-stage surgery if necessary. Before finishing the surgical procedure, the volunteers will be randomly assigned to one of the two arms by opening sealed envelopes with a random sequence generated by Excel (Microsoft, Redmond, Washington, USA). Therefore, the surgeon will identify each volunteer's arm only after the end of drilling, insertion and stabilization of the implants. Each implant allocated at the control arm (active comparator) will receive conventional treatment with three abutment disconnections and reconnections. At the experimental arm, each implant will receive the prosthetic abutment in a definitive way immediately at the surgical procedure, avoiding any abutment disconnection. The surgeries of both arms will be finished with suture, drug prescription and postoperative recommendations. All implants will receive temporary crowns at three months and definitive prosthesis until six months after surgery. Intraoral radiographs will be done with paralleling technique immediately after surgery (baseline) and at 3, 6, 12 and 24 months later. The radiographs will have its dimensions corrected at the ImageJ software (National Institutes of Health, Bethesda, Maryland, USA) having implant known dimensions as reference. Each implant will have its radiographs evaluated by a previously calibrated examiner with a minimum of 0.8 intra-rater reliability for the intraclass correlation coefficient. The examiner will not know to which arm the X-rays belong. Primary and secondary outcomes data will be submitted to normality test and compared using statistical tests for paired and unpaired samples.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Bone Loss
Keywords
dental implant, bone preservation, definitive abutment, one abutment one time

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Definitive abutment
Arm Type
Experimental
Arm Description
Implant surgery. No abutment dis-/reconnections.
Arm Title
Conventional treatment
Arm Type
Active Comparator
Arm Description
Implant surgery. Three abutment dis-/reconnections.
Intervention Type
Procedure
Intervention Name(s)
Implant surgery
Intervention Description
The volunteers will receive one or two dental implant(s) placed by a surgical procedure, under local anesthesia and careful soft and hard tissue handling. After implant insertion, the volunteers will be randomly assigned to one arm.
Intervention Type
Device
Intervention Name(s)
Three abutment dis-/reconnections.
Intervention Description
At the active comparator arm, each implant will receive a titanium healing abutment during the surgery, according to manufacturer's recommendations. Three dis-/reconnections of abutments will be performed after the soft tissue healing period: the first, after 8 weeks, for adjustment of the emergence profile by healing abutment changing; the second, 10 weeks after surgery, for intra-oral prosthetic abutment selection; and the third, 12 weeks after surgery, for the prosthetic abutment definitive connection with the manufacturer recommended torque.
Intervention Type
Device
Intervention Name(s)
No abutment dis-/reconnections.
Intervention Description
Each experimental arm implant will receive its definitive prosthetic abutment at the surgical procedure. The manufacturer recommended torque will be applied so that no disconnection of the abutment will occur during and after completion of the treatment. The abutment will receive healing caps, which shall remain in position until the end of 12 weeks after surgery.
Primary Outcome Measure Information:
Title
Peri-implant marginal bone level change.
Description
To estimate the gingival margin stability and the long-term success of implant-supported restorations, the peri-implant marginal bone level will be assessed as primary outcome through intraoral radiographs, in a perspective of bone maintenance, bone loss or bone gain.
Time Frame
2, 6, 12 and 24 months after implant surgery.
Secondary Outcome Measure Information:
Title
Implant stability change.
Description
The implant stability will be measured using a resonance frequency analysis equipment to confirm the implant osseointegration.
Time Frame
3 and 6 months after implant surgery.
Title
Gingival level change.
Description
The gingival level will be measured using a periodontal probe and an acrylic stent as a reference.
Time Frame
6, 12 and 24 months after implant surgery.
Title
Peri-implant probing depth change.
Description
To evaluate the peri-implant health, the probing depth will be assessed in 6 areas around the implant using the prosthetic abutment as a reference.
Time Frame
12 and 24 months after implant surgery.
Title
Bleeding on probing change.
Description
To evaluate the peri-implant health, the bleeding on probing will be observer or not at until 10 seconds after peri-implant probing.
Time Frame
12 and 24 months after implant surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Partially edentulous patients requiring dental implant treatment for one or two dental units; Occlusal stability and regular occlusal plane; Enough space for implant and prosthesis; Good periodontal health Keratinized mucosa width > 4mm; Implant primary stability > 65 ISQ and insertion torque > 20Ncm; Exclusion Criteria: Diabetes mellitus; Treatment with bisphosphonates; Head and neck irradiation; General contraindications to oral surgery; Pregnancy; Bone graft; Bruxism; Smoking habits.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodrigo O. Rego, PhD
Organizational Affiliation
Universidade Federal do Ceara
Official's Role
Study Director
Facility Information:
Facility Name
Fortaleza University; Health Sciences Center; School of Dentistry.
City
Fortaleza
State/Province
Ceará
ZIP/Postal Code
60811-905
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
6809663
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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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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Implant Abutment Dis-/Reconnection and Peri-Implant Marginal Bone Loss.

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