Pateint With Badely Decayed Anterior TeethNCT03841851
Immediate Implant Placement With Immediate Loading With and Without Connective Tissue Graft
A study testing sub epithelial connective tissue graft in people with Pateint With Badely Decayed Anterior Teeth, run by Cairo University.
Trial summary
extraction of badely decayed anterior teeth immediate implant placement with immediate temporaization Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pateint With Badely Decayed Anterior Teeth
- What is being tested?
- sub epithelial connective tissue graft
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2019to 1 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Aesthetic Outcome of Immediate Implant Placement With Immediate Loading With and Without Sub Epithelial Connective Tissue Graft
extraction of badely decayed anterior teeth immediate implant placement with immediate temporaization
Read the 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 .
- Being tested
- sub epithelial connective tissue graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sub epithelial connective tissue graftProcedure or surgery
- 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
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: Procedure: sub epithelial connective tissue graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pink esthetics
evaluation of esthetic outcome using pink esthetic score
Measured: every 2 weeks for 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start15 Jun 2019 (estimated)
- Primary completion1 Jul 2019 (estimated)
- Study completion1 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Pateint With Badely Decayed Anterior TeethStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Habib, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03841851
- Sponsor's protocol ID
- cairo univ
- Status last verified
- Feb 2019
- First submitted
- 11 Feb 2019
- Last updated
- 15 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
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.
PubMed 356184Salama 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.
PubMed 9468854Albrektsson 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.
PubMed 3527955Adell 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.
PubMed 2094653Schnitman 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.
PubMed 9274078Testori 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.
PubMed 15142089Redemagni 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.
PubMed 20111758Botticelli 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.
PubMed 15367183Sanz 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.
PubMed 19922492Cosyn 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.
PubMed 22509794
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aesthetic Outcome of Immediate Implant Placement With Immediate Loading With and Without Sub Epithelial Connective Tissue Graft
- ClinicalTrials.gov ID
- NCT03841851
- Acronym / sponsor ID
- cairo univ
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Jun 2019 (estimated)
- Primary completion
- 1 Jul 2019 (estimated)
- Study completion
- 1 Jul 2019 (estimated)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
extraction of badely decayed anterior teeth immediate implant placement with immediate temporaization
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | 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 . |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Procedure or surgery | temporization with soft tissue graft |
Primary outcome
Pink esthetics
Time frame: every 2 weeks for 3 months
evaluation of esthetic outcome using pink esthetic score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Background: PubMed 356184Branemark 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.
- Background: PubMed 9468854Salama 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.
- Background: PubMed 3527955Albrektsson 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.
- Background: PubMed 2094653Adell 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.
- Background: PubMed 9274078Schnitman 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.
- Background: PubMed 15142089Testori 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.
- Background: PubMed 20111758Redemagni 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.
- Background: PubMed 15367183Botticelli 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.
- Background: PubMed 19922492Sanz 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.
- Background: PubMed 22509794Cosyn 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.
- Individual participant dataSharing planned: No. 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
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing sub epithelial connective tissue graft in people with Pateint With Badely Decayed Anterior Teeth, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pink esthetics (time frame: every 2 weeks for 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03841851, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.