Computer-guided Versus Free- Hand Immediate Implant Placement

NCT03211819 | Completed DMC

• 1 other identifier: Prosthodontic Department
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Implant

Keywords

immediate; esthetics

Outcome Measures

Primary Outcomes (2)

• Pink Esthetic Score (PES)

  a scoring system of five points are to be checked and evaluated where 0=incomplete; 1= partially present; 2= completely present

  1 week postoperative to surgery

• Pink Esthetic Score (PES)

  a scoring system of five points are to be checked and evaluated where 0=incomplete; 1= partially present; 2= completely present

  1 week postoperative to definitive crown

Secondary Outcomes (1)

• Gingival recession

  1 week and 6 month postoperatively

Study Arms (2)

computer guided placement

EXPERIMENTAL

In the test group, the computer guided surgical guide manufactured using zenith 3D printer (Dentis, Daegu, Korea) will be used for implant drilling and placement (s-Clean Tapered Implants, Dentis Co., Ltd., Woram-Dong, Dalseo-Gu, Daegu, South Korea) following the manufacture's instructions. 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 (Structur 2 SC / QM,VOCO GmbH, Germany) will be injected into the vacuum sheet corresponding to the implant site to construct the temporary crown.

Procedure: immediate implant placement

free hand placement

ACTIVE COMPARATOR

in the control group, the implant will be placed it the socket using free hand technique and according to the manufacturing instruction's (s-Clean Tapered Implants, Dentis Co., Ltd., Woram-Dong, Dalseo-Gu, Daegu, South Korea) . 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 (Structur 2 SC / QM,VOCO GmbH,Germany)will be injected into the vacuum sheet corresponding to the implant site to construct the temporary crown.

Procedure: immediate implant placement

Interventions

immediate implant placement PROCEDURE

A prophylactic antibiotic(Flumox 500mg, Egyptian Int. Pharmaceutical Industries Co.,A.R.E.) 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 (Nordent Manufacturing Inc. U.S.A), 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.

computer guided placement; free hand placement

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Oral and Dental Medicine

Cairo, 1234, Egypt

Location

Related Publications (1)

• 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).

  BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: due to the nature of the trial only the outcome assessror will be masked from the intervention or control group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant Lecturer- Prosthodontic Department- Faculty of Dentistry- Principle Investigator

Study Record Dates

• First Submitted: July 6, 2017
• First Posted: July 7, 2017
• Study Start: February 15, 2019
• Primary Completion: December 1, 2019
• Study Completion: January 1, 2020
• Last Updated: June 5, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)