NCT03841851

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 15, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

June 15, 2019

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

16 days

First QC Date

February 11, 2019

Last Update Submit

February 13, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pink esthetics

    evaluation of esthetic outcome using pink esthetic score

    every 2 weeks for 3 months

Study Arms (2)

temporization without soft tissue graft

NO INTERVENTION

* 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 .

temporization with soft tissue graft

ACTIVE COMPARATOR

* 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

Interventions

* 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

temporization with soft tissue graft

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • 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.

    PMID: 356184BACKGROUND
  • 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.

    PMID: 9468854BACKGROUND
  • 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.

    PMID: 3527955BACKGROUND
  • 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.

    PMID: 2094653BACKGROUND
  • 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.

    PMID: 9274078BACKGROUND
  • 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.

    PMID: 15142089BACKGROUND
  • 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.

    PMID: 20111758BACKGROUND
  • 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.

    PMID: 15367183BACKGROUND
  • 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.

    PMID: 19922492BACKGROUND
  • 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.

    PMID: 22509794BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Each patient will be given acode by the researcher and the observers will be blind to which group this case belong
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator(doctor)

Study Record Dates

First Submitted

February 11, 2019

First Posted

February 15, 2019

Study Start

June 15, 2019

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

February 15, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

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