Dental DiseasesNCT03851224
Immediate Implant With no Graft , Autogenous Graft or Xenograft.
A study testing study group and study group 2 in people with Dental Diseases, run by Cairo University at 1 site in Egypt.
Trial summary
Immediate implant placement with no graft , autogenous graft or xenograft with provisionalization. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dental Diseases
- What is being tested?
- study group and study group 2
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2018to 1 Nov 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 teeth
Who cannot join
- intra oral pathology and systemic conditions that contraindicate dental implants.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry Cairo University
Cairo, Al- Manial Egypt, 11553
Mostafa M Attiea, B.S.D, 00201009080414 ext. 01111634311, mosattiea3110@gmail.com
Mostafa M Attiea, B.S.D, 00201009080414 ext. 01111634311, ahmed.zayed@dentistry.cu.edu.eg
About this study
Official title: Immediate Implant Placement in Maxillary Esthetic Zone Without Augmenting the Jumping Gap Versus the Use of Autogenous Bone Particulates or Demineralized Bovine Bone Graft (Randomized Clinical Trial)
Immediate implant placement with no graft , autogenous graft or xenograft with provisionalization.
Read the detailed description
Immediate implant placement in maxillary esthetic zone without augmenting the jumping gap versus the use of autogenous bone particulates or demineralized bovine bone graft (Randomized Clinical Trial)
- Conditions
- Dental Diseases
- Being tested
- control group, study group, study group 2
- Medical subject headings
- Stomatognathic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
control groupProcedure or surgery
immediate implant with immediate loading using no graft
study groupProcedure or surgery
immediate implant with immediate loading using autogenous bone graft
study group 2Procedure or surgery
immediate implant with immediate loading using (Geistlich Bio-Oss®) xenograft
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | under local anaesthesia patients hopeless teeth are be extracted. then immediate implant is palced with no graft and immediate temporary prothesis is loaded upon the immediate implants.implant stability is evaluated immediately and 3 months post operatively Receives: Procedure: control group |
| study group | Active comparator | under local anaesthesia patients hopeless teeth are be extracted. then immediate implant is palced with autogenous bone graft and immediate temporary prothesis is loaded upon the immediate implants.implant stability is evaluated immediately and 3 months post operatively Receives: Procedure: study group |
| study group 2 | Active comparator | under local anaesthesia patients hopeless teeth are be extracted. then immediate implant is palced withxenograft and immediate temporary prothesis is loaded upon the immediate implants.implant stability is evaluated immediately and 3 months post operatively Receives: Procedure: study group 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaliuation of labial bone changes
Evaluation the thickness of the facial bony wall by millimeter in the CBCT
Measured: 6 month
evaluation of marginal bone changes
evaluation of interproximal bone changes by millimeter in the CBCT
Measured: 6 months
Secondary outcomes (1)
pink aesthetic score
evaluation of soft tissue changes surround implant by pink aesthetic score
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2019
- Study start1 Sep 2018
- Primary completion1 Sep 2019 (estimated)
- Study completion1 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Dental DiseasesStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Immediate implant placement in maxillary esthetic zone without augmenting the jumping gap versus the use of autogenous bone particulates or demineralized bovine bone graft.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mostafa attiea, Cairo University
- Investigators
- Mostafa M Attiea, B.S.D, Principal investigator, Egypt Faculty of dentistry Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03851224
- Sponsor's protocol ID
- immediate implants
- Status last verified
- Feb 2019
- First submitted
- 11 Sep 2018
- Last updated
- 22 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: web sites and papers
Publications
Papaspyridakos P, Chen CJ, Singh M, Weber HP, Gallucci GO. Success criteria in implant dentistry: a systematic review. J Dent Res. 2012 Mar;91(3):242-8. doi: 10.1177/0022034511431252. Epub 2011 Dec 8.
PubMed 22157097Schulte W, Kleineikenscheidt H, Lindner K, Schareyka R. [The Tubingen immediate implant in clinical studies]. Dtsch Zahnarztl Z. 1978 May;33(5):348-59. German.
PubMed 348452Chen ST, Wilson TG Jr, Hammerle CH. Immediate or early placement of implants following tooth extraction: review of biologic basis, clinical procedures, and outcomes. Int J Oral Maxillofac Implants. 2004;19 Suppl:12-25.
PubMed 15635942Elian N, Cho SC, Froum S, Smith RB, Tarnow DP. A simplified socket classification and repair technique. Pract Proced Aesthet Dent. 2007 Mar;19(2):99-104; quiz 106.
PubMed 17491484Becker W, Becker BE. Guided tissue regeneration for implants placed into extraction sockets and for implant dehiscences: surgical techniques and case report. Int J Periodontics Restorative Dent. 1990;10(5):376-91. No abstract available.
PubMed 2098360Tan-Chu JH, Tuminelli FJ, Kurtz KS, Tarnow DP. Analysis of buccolingual dimensional changes of the extraction socket using the "ice cream cone" flapless grafting technique. Int J Periodontics Restorative Dent. 2014 May-Jun;34(3):399-403. doi: 10.11607/prd.1605.
PubMed 24804291Conrad EU, Gretch DR, Obermeyer KR, Moogk MS, Sayers M, Wilson JJ, Strong DM. Transmission of the hepatitis-C virus by tissue transplantation. J Bone Joint Surg Am. 1995 Feb;77(2):214-24. doi: 10.2106/00004623-199502000-00007.
PubMed 7844127Tarnow DP, Chu SJ, Salama MA, Stappert CF, Salama H, Garber DA, Sarnachiaro GO, Sarnachiaro E, Gotta SL, Saito H. Flapless postextraction socket implant placement in the esthetic zone: part 1. The effect of bone grafting and/or provisional restoration on facial-palatal ridge dimensional change-a retrospective cohort study. Int J Periodontics Restorative Dent. 2014 May-Jun;34(3):323-31. doi: 10.11607/prd.1821.
PubMed 24804283Kan JY, Rungcharassaeng K, Lozada JL, Zimmerman G. Facial gingival tissue stability following immediate placement and provisionalization of maxillary anterior single implants: a 2- to 8-year follow-up. Int J Oral Maxillofac Implants. 2011 Jan-Feb;26(1):179-87.
PubMed 21365054Chu SJ, Hochman MN, Tan-Chu JH, Mieleszko AJ, Tarnow DP. A novel prosthetic device and method for guided tissue preservation of immediate postextraction socket implants. Int J Periodontics Restorative Dent. 2014;34 Suppl 3:s9-17. doi: 10.11607/prd.1749.
PubMed 24956098Ritter AV. Xerostomia (dry mouth). J Esthet Restor Dent. 2006;18(5):306. doi: 10.1111/j.1708-8240.2006.00041.x. No abstract available.
PubMed 16987328Kan JY, Rungcharassaeng K, Lozada J. Immediate placement and provisionalization of maxillary anterior single implants: 1-year prospective study. Int J Oral Maxillofac Implants. 2003 Jan-Feb;18(1):31-9.
PubMed 12608666
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Implant Placement in Maxillary Esthetic Zone Without Augmenting the Jumping Gap Versus the Use of Autogenous Bone Particulates or Demineralized Bovine Bone Graft (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT03851224
- Acronym / sponsor ID
- immediate implants
- Conditions
- Dental Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Sep 2019 (estimated)
- Study completion
- 1 Nov 2019 (estimated)
- First posted
- 22 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.
Immediate implant placement with no graft , autogenous graft or xenograft with provisionalization.
Detailed description
Immediate implant placement in maxillary esthetic zone without augmenting the jumping gap versus the use of autogenous bone particulates or demineralized bovine bone graft (Randomized Clinical Trial)
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Immediate implant placement in maxillary esthetic zone without augmenting the jumping gap versus the use of autogenous bone particulates or demineralized bovine bone graft.
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Procedure: control groupunder local anaesthesia patients hopeless teeth are be extracted. then immediate implant is palced with no graft and immediate temporary prothesis is loaded upon the immediate implants.implant stability is evaluated immediately and 3 months post operatively |
| study group | Active comparator | Procedure: study groupunder local anaesthesia patients hopeless teeth are be extracted. then immediate implant is palced with autogenous bone graft and immediate temporary prothesis is loaded upon the immediate implants.implant stability is evaluated immediately and 3 months post operatively |
| study group 2 | Active comparator | Procedure: study group 2under local anaesthesia patients hopeless teeth are be extracted. then immediate implant is palced withxenograft and immediate temporary prothesis is loaded upon the immediate implants.implant stability is evaluated immediately and 3 months post operatively |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients with non-restorable teeth
Key exclusion criteria (1 listed)
- intra oral pathology and systemic conditions that contraindicate dental implants.
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 |
|---|---|---|
| control groupimmediate implant with immediate loading using no graft | Procedure or surgery | control group |
| study groupimmediate implant with immediate loading using autogenous bone graft | Procedure or surgery | study group |
| study group 2immediate implant with immediate loading using (Geistlich Bio-Oss®) xenograft | Procedure or surgery | study group 2 |
Primary outcome
evaliuation of labial bone changes
Time frame: 6 month
Evaluation the thickness of the facial bony wall by millimeter in the CBCT
evaluation of marginal bone changes
Time frame: 6 months
evaluation of interproximal bone changes by millimeter in the CBCT
1 secondary outcome
pink aesthetic score
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2019.
- Background: PubMed 22157097Papaspyridakos P, Chen CJ, Singh M, Weber HP, Gallucci GO. Success criteria in implant dentistry: a systematic review. J Dent Res. 2012 Mar;91(3):242-8. doi: 10.1177/0022034511431252. Epub 2011 Dec 8.
- Background: PubMed 348452Schulte W, Kleineikenscheidt H, Lindner K, Schareyka R. [The Tubingen immediate implant in clinical studies]. Dtsch Zahnarztl Z. 1978 May;33(5):348-59. German.
- Background: PubMed 15635942Chen ST, Wilson TG Jr, Hammerle CH. Immediate or early placement of implants following tooth extraction: review of biologic basis, clinical procedures, and outcomes. Int J Oral Maxillofac Implants. 2004;19 Suppl:12-25.
- Background: PubMed 17491484Elian N, Cho SC, Froum S, Smith RB, Tarnow DP. A simplified socket classification and repair technique. Pract Proced Aesthet Dent. 2007 Mar;19(2):99-104; quiz 106.
- Background: PubMed 2098360Becker W, Becker BE. Guided tissue regeneration for implants placed into extraction sockets and for implant dehiscences: surgical techniques and case report. Int J Periodontics Restorative Dent. 1990;10(5):376-91. No abstract available.
- Background: PubMed 24804291Tan-Chu JH, Tuminelli FJ, Kurtz KS, Tarnow DP. Analysis of buccolingual dimensional changes of the extraction socket using the "ice cream cone" flapless grafting technique. Int J Periodontics Restorative Dent. 2014 May-Jun;34(3):399-403. doi: 10.11607/prd.1605.
- Background: PubMed 7844127Conrad EU, Gretch DR, Obermeyer KR, Moogk MS, Sayers M, Wilson JJ, Strong DM. Transmission of the hepatitis-C virus by tissue transplantation. J Bone Joint Surg Am. 1995 Feb;77(2):214-24. doi: 10.2106/00004623-199502000-00007.
- Background: PubMed 24804283Tarnow DP, Chu SJ, Salama MA, Stappert CF, Salama H, Garber DA, Sarnachiaro GO, Sarnachiaro E, Gotta SL, Saito H. Flapless postextraction socket implant placement in the esthetic zone: part 1. The effect of bone grafting and/or provisional restoration on facial-palatal ridge dimensional change-a retrospective cohort study. Int J Periodontics Restorative Dent. 2014 May-Jun;34(3):323-31. doi: 10.11607/prd.1821.
- Background: PubMed 21365054Kan JY, Rungcharassaeng K, Lozada JL, Zimmerman G. Facial gingival tissue stability following immediate placement and provisionalization of maxillary anterior single implants: a 2- to 8-year follow-up. Int J Oral Maxillofac Implants. 2011 Jan-Feb;26(1):179-87.
- Background: PubMed 24956098Chu SJ, Hochman MN, Tan-Chu JH, Mieleszko AJ, Tarnow DP. A novel prosthetic device and method for guided tissue preservation of immediate postextraction socket implants. Int J Periodontics Restorative Dent. 2014;34 Suppl 3:s9-17. doi: 10.11607/prd.1749.
- Background: PubMed 16987328Ritter AV. Xerostomia (dry mouth). J Esthet Restor Dent. 2006;18(5):306. doi: 10.1111/j.1708-8240.2006.00041.x. No abstract available.
- Background: PubMed 12608666Kan JY, Rungcharassaeng K, Lozada J. Immediate placement and provisionalization of maxillary anterior single implants: 1-year prospective study. Int J Oral Maxillofac Implants. 2003 Jan-Feb;18(1):31-9.
- Individual participant dataSharing planned: Undecided. web sites and papers
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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.
Mostafa M Attiea, B.S.D principal investigator
Egypt Faculty of dentistry Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing study group and study group 2 in people with Dental Diseases, run by Cairo University at 1 site in Egypt.
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 1 inclusion and 1 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 22 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Mostafa M Attiea, B.S.D (00201009080414 ext. 01111634311, mosattiea3110@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaliuation of labial bone changes (time frame: 6 month). The study lists 2 primary outcomes in all. 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 NCT03851224, which also lists 12 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 22 Feb 2019.