- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03841851
Immediate Implant Placement With Immediate Loading With and Without Connective Tissue Graft
Aesthetic Outcome of Immediate Implant Placement With Immediate Loading With and Without Sub Epithelial Connective Tissue Graft
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Intra-operative procedure:
Local anesthesia will be injected intra-orally at the implant site. Atraumatic extraction of badley decayed teeth in the aesthetic area .
For group A :
traditional drilling for immediate implant placement . immediate temporization .
For group B :
traditional drilling for immediate implant placement . immediate temporization . subepithelial connective tissue graft from the palate .
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with non-restorable maxillary anterior teeth indicated for implant placement.
- Both sexes.
- No intraoral soft and hard tissue pathology.
- No systemic condition that contraindicate implant placement.
Exclusion Criteria:
- Patients with systemic disease that may affect bone quality.
- Patients with poor oral hygiene and active periodontal diseases.
- Heavy smokers more than 20 cigarettes per day.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: temporization without soft tissue graft
|
|
|
Active Comparator: temporization with soft tissue graft
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pink esthetics
Time Frame: every 2 weeks for 3 months
|
evaluation of esthetic outcome using pink esthetic score
|
every 2 weeks for 3 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Branemark PI, Hansson BO, Adell R, Breine U, Lindstrom J, Hallen O, Ohman A. Osseointegrated implants in the treatment of the edentulous jaw. Experience from a 10-year period. Scand J Plast Reconstr Surg Suppl. 1977;16:1-132. No abstract available.
- Testori T, Meltzer A, Del Fabbro M, Zuffetti F, Troiano M, Francetti L, Weinstein RL. Immediate occlusal loading of Osseotite implants in the lower edentulous jaw. A multicenter prospective study. Clin Oral Implants Res. 2004 Jun;15(3):278-84. doi: 10.1111/j.1600-0501.2004.01013.x.
- Botticelli D, Berglundh T, Lindhe J. Hard-tissue alterations following immediate implant placement in extraction sites. J Clin Periodontol. 2004 Oct;31(10):820-8. doi: 10.1111/j.1600-051X.2004.00565.x.
- Albrektsson T, Zarb G, Worthington P, Eriksson AR. The long-term efficacy of currently used dental implants: a review and proposed criteria of success. Int J Oral Maxillofac Implants. 1986 Summer;1(1):11-25. No abstract available.
- Sanz M, Cecchinato D, Ferrus J, Pjetursson EB, Lang NP, Lindhe J. A prospective, randomized-controlled clinical trial to evaluate bone preservation using implants with different geometry placed into extraction sockets in the maxilla. Clin Oral Implants Res. 2010 Jan;21(1):13-21. doi: 10.1111/j.1600-0501.2009.01824.x. Epub 2009 Nov 18.
- Salama H, Salama MA, Li TF, Garber DA, Adar P. Treatment planning 2000: an esthetically oriented revision of the original implant protocol. J Esthet Dent. 1997;9(2):55-67. doi: 10.1111/j.1708-8240.1997.tb00919.x.
- Adell R, Eriksson B, Lekholm U, Branemark PI, Jemt T. Long-term follow-up study of osseointegrated implants in the treatment of totally edentulous jaws. Int J Oral Maxillofac Implants. 1990 Winter;5(4):347-59.
- Schnitman PA, Wohrle PS, Rubenstein JE, DaSilva JD, Wang NH. Ten-year results for Branemark implants immediately loaded with fixed prostheses at implant placement. Int J Oral Maxillofac Implants. 1997 Jul-Aug;12(4):495-503.
- Redemagni M, Cremonesi S, Garlini G, Maiorana C. Soft tissue stability with immediate implants and concave abutments. Eur J Esthet Dent. 2009 Winter;4(4):328-37.
- Cosyn J, Hooghe N, De Bruyn H. A systematic review on the frequency of advanced recession following single immediate implant treatment. J Clin Periodontol. 2012 Jun;39(6):582-9. doi: 10.1111/j.1600-051X.2012.01888.x. Epub 2012 Apr 18.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- cairo univ
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Local anesthesia will be injected intra-orally at the implant site. Atraumatic extraction of badley decayed teeth in the aesthetic area .
For group A :
- traditional drilling for immediate implant placement .
- immediate temporization .
For group B :
- traditional drilling for immediate implant placement .
- immediate temporization .
- subepithelial connective tissue graft from the palate
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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