Computer-guided Versus Free- Hand Immediate Implant Placement - Full Text View

Purpose

Patients with fractured anterior teeth indicated for extraction will be recruited to the study. After Extraction of the tooth the socket will be evaluated and if eligible for immediate implant placement, implants will be placed either by free hand or computer guided technique. The pink esthetic score will be evaluated to be the primary outcome.

Condition	Intervention
Dental Implant	Procedure: immediate implant placement


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Outcomes Assessor Masking Description: due to the nature of the trial only the outcome assessror will be masked from the intervention or control group Primary Purpose: Treatment
Official Title:	Esthetic Outcome of Computer-guided Versus Free- Hand Immediate Implant Placement in Fresh Extraction Sockets in Esthetic Zone, a Randomized Clinical Trial.

Further study details as provided by Ahmed Kotb, Cairo University:

Primary Outcome Measures:

Pink Esthetic Score (PES) [ Time Frame: 1 week postoperatively ]
a scoring system of seven points are to be checked and evaluated where 0=incomplete; 1= partially present; 2= completely present

Secondary Outcome Measures:

Gingival recession [ Time Frame: 1 week and 6 month postoperatively ]
a periodontal probe will be used to measure if there is any mid facial gingival recession from the implant margin to the gingival tissue


Estimated Enrollment:	20
Anticipated Study Start Date:	September 1, 2017
Estimated Study Completion Date:	March 1, 2020
Estimated Primary Completion Date:	September 1, 2019 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: computer guided placement In the test group, the computer guided surgical guide will be used for implant drilling and placement following the manufacture's instructions. While in the control group, after tooth or root extraction implants will be placed free hand guided by the extraction sockets. Then in implants with primary stability > 35 Ncm2, the final abutment will be placed and any further adjustment would be done immediately in the lab and repositioned in place. Then the vacuum stent will be checked in its place again intraorally, then a chair side tooth coloured autopolymerizing resin will be injected into the vacuum sheet corresponding to the implant site to construct the temporary crown.	Procedure: immediate implant placement A prophylactic antibiotic would be given to the patient 3 days prior to the surgery. Then on the day of surgery, (AK) will extract the remaining root or tooth in an atraumatic procedure using lancet, periotome, minimal force and rotational movement. After extraction the socket will be examined for intact labial and palatal bone using depth probe. If all walls are intact the socket would be eligible for immediate implant placement.
Active Comparator: free hand placement in the control group, the implant will be placed it the socket using free hand technique and according to the manufacturing instruction's. the implants will be placed guided by the socket of the root. Then in implants with primary stability > 35 Ncm2, the final abutment will be placed and any further adjustment would be done immediately in the lab and repositioned in place. Then the vacuum stent will be checked in its place again intraorally, then a chair side tooth coloured autopolymerizing resin will be injected into the vacuum sheet corresponding to the implant site to construct the temporary crown.	Procedure: immediate implant placement A prophylactic antibiotic would be given to the patient 3 days prior to the surgery. Then on the day of surgery, (AK) will extract the remaining root or tooth in an atraumatic procedure using lancet, periotome, minimal force and rotational movement. After extraction the socket will be examined for intact labial and palatal bone using depth probe. If all walls are intact the socket would be eligible for immediate implant placement.

Arms

Assigned Interventions

Experimental: computer guided placement

In the test group, the computer guided surgical guide will be used for implant drilling and placement following the manufacture's instructions.

While in the control group, after tooth or root extraction implants will be placed free hand guided by the extraction sockets.

Then in implants with primary stability > 35 Ncm2, the final abutment will be placed and any further adjustment would be done immediately in the lab and repositioned in place. Then the vacuum stent will be checked in its place again intraorally, then a chair side tooth coloured autopolymerizing resin will be injected into the vacuum sheet corresponding to the implant site to construct the temporary crown.

Procedure: immediate implant placement

A prophylactic antibiotic would be given to the patient 3 days prior to the surgery. Then on the day of surgery, (AK) will extract the remaining root or tooth in an atraumatic procedure using lancet, periotome, minimal force and rotational movement.

After extraction the socket will be examined for intact labial and palatal bone using depth probe. If all walls are intact the socket would be eligible for immediate implant placement.

Active Comparator: free hand placement

in the control group, the implant will be placed it the socket using free hand technique and according to the manufacturing instruction's. the implants will be placed guided by the socket of the root.

Then in implants with primary stability > 35 Ncm2, the final abutment will be placed and any further adjustment would be done immediately in the lab and repositioned in place. Then the vacuum stent will be checked in its place again intraorally, then a chair side tooth coloured autopolymerizing resin will be injected into the vacuum sheet corresponding to the implant site to construct the temporary crown.

Procedure: immediate implant placement

A prophylactic antibiotic would be given to the patient 3 days prior to the surgery. Then on the day of surgery, (AK) will extract the remaining root or tooth in an atraumatic procedure using lancet, periotome, minimal force and rotational movement.

After extraction the socket will be examined for intact labial and palatal bone using depth probe. If all walls are intact the socket would be eligible for immediate implant placement.

Show Detailed Description

Eligibility


Ages Eligible for Study:	18 Years to 60 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Patients with teeth or remaining roots indicated for extraction in the esthetic zone and eligible for immediate implant placement
- Sufficient bone labially (at least 1.5-2 mm) assessed after cone beam computer tomography (CBCT) scan
- Presence of adequate mesio-distal length between the adjacent natural teeth (at least 7 mm), measured on the study cast
- No overeruption of the opposing teeth to avoid any premature contact with the temporary crown during the osseointegration period.

Exclusion Criteria:

Presence of active sings or symptoms of acute infection in the tooth or the remaining root
- Heavy smokers (more than 2 packs per day)
- Parafunctional habits (clenching or bruxism) diagnosed by history taking and observation of the occlusal surface of the posterior teeth for wear facets
- Patients with poor oral hygiene
- Pregnant women
- Any systemic condition that may interfere with osseointegration (as uncontrolled diabetes, recent head and neck radiation)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03211819

Locations


Egypt
Faculty of Oral and Dental Medicine	Not yet recruiting
Cairo, Egypt, 1234
Contact: Mr (+202) 23634965 dentmail@dentistry.cu.edu.eg
Contact: Ahmed Kotb +201006697790 ahmed.kotb@dentistry.cu.edu.eg

Sponsors and Collaborators

Cairo University

More Information

Publications:

Arısan, V., Karabuda, C. Z., Mumcu, E. & Özdemir, T. Implant Positioning Errors in Freehand and Computer-Aided Placement Methods: A Single-Blind Clinical Comparative Study. Int. J. Oral Maxillofac. Implants 28, 190-204 (2013). 2. Khzam, N. et al. Systematic Review of Soft Tissue Alterations and Esthetic Outcomes Following Immediate Implant Placement and Restoration of Single Implants in the Anterior Maxilla. J. Periodontol. 86, 1321-30 (2015). 3. SCHROPP, L. & ISIDOR, F. Timing of implant placement relative to tooth extraction. J. Oral Rehabil. 35, 33-43 (2008). 4. Al-Sabbagh, M. & Kutkut, A. Immediate Implant Placement. Dent. Clin. North Am. 59, 73-95 (2015).


Responsible Party:	Ahmed Kotb, Dr., Cairo University
ClinicalTrials.gov Identifier:	NCT03211819 History of Changes
Other Study ID Numbers:	Prosthodontic Department
Study First Received:	July 6, 2017
Last Updated:	July 6, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No


Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by Ahmed Kotb, Cairo University:


immediate esthetics

ClinicalTrials.gov processed this record on July 11, 2017

Computer-guided Versus Free- Hand Immediate Implant Placement (RCT)