Immediate Implant Placement With Immediate Loading With and Without Connective Tissue Graft

• Sponsor: Cairo University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03841851
• Collaborator: (none)
• Enrollment: 2
• Arms: 2
• Anticipated Duration (Days): 16

Study Details

Study Description

Brief Summary

extraction of badely decayed anterior teeth immediate implant placement with immediate temporaization

Condition or Disease	Intervention/Treatment	Phase
Pateint With Badely Decayed Anterior Teeth	Procedure: sub epithelial connective tissue graft	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 2 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: This study will be conducted on patients with badely decayed teeth in aesthetic zone and need immediate fixed restoration . This study is to be conducted in Dental Implant Clinic, Faculty of Dentistry, Cairo University, Egypt. All the patients will be entailed about the study and given their approval to participate on written consent.This study will be conducted on patients with badely decayed teeth in aesthetic zone and need immediate fixed restoration . This study is to be conducted in Dental Implant Clinic, Faculty of Dentistry, Cairo University, Egypt. All the patients will be entailed about the study and given their approval to participate on written consent.
• Masking: Double (Participant, Investigator)
• Masking Description: Each patient will be given acode by the researcher and the observers will be blind to which group this case belong
• Primary Purpose: Other
• Official Title: Aesthetic Outcome of Immediate Implant Placement With Immediate Loading With and Without Sub Epithelial Connective Tissue Graft
• Anticipated Study Start Date: Jun 15, 2019
• Anticipated Primary Completion Date: Jul 1, 2019
• Anticipated Study Completion Date: Jul 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: temporization without soft tissue graft Local anesthesia will be injected intra-orally at the implant site. Atraumatic extraction of badley decayed teeth in the aesthetic area traditional drilling for immediate implant placement . immediate temporization .
Active Comparator: temporization with soft tissue graft Local anesthesia will be injected intra-orally at the implant site. Atraumatic extraction of badley decayed teeth in the aesthetic area traditional drilling for immediate implant placement . immediate temporization . subepithelial connective tissue graft from the palate .	Procedure: sub epithelial connective tissue graft; Local anesthesia will be injected intra-orally at the implant site. Atraumatic extraction of badley decayed teeth in the aesthetic area traditional drilling for immediate implant placement . immediate temporization . subepithelial connective tissue graft from the palate

Outcome Measures

Primary Outcome Measures

1. Pink esthetics [every 2 weeks for 3 months]

   evaluation of esthetic outcome using pink esthetic score

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Adell R, Eriksson B, Lekholm U, Brånemark 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.
• 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. Review.
• 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.
• Brånemark PI, Hansson BO, Adell R, Breine U, Lindström J, Hallén 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.
• 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. Review.
• 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.
• 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.
• 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.
• Schnitman PA, Wöhrle PS, Rubenstein JE, DaSilva JD, Wang NH. Ten-year results for Brånemark implants immediately loaded with fixed prostheses at implant placement. Int J Oral Maxillofac Implants. 1997 Jul-Aug;12(4):495-503.
• 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.

• Responsible Party: Mohamed Habib, principle investigator(doctor), Cairo University
• ClinicalTrials.gov Identifier: NCT03841851
• Other Study ID Numbers: cairo univ
• First Posted: Feb 15, 2019
• Last Update Posted: Feb 15, 2019
• Last Verified: Feb 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Feb 15, 2019