Implant Site ReactionNCT03305679
Clinical Efficacy of the Immediate Implant Loading
A study testing Direct provisional technique and Indirect Provisional technique in people with Implant Site Reaction, run by Damascus University at 3 sites in 2 countries.
Trial summary
Aim: The aim of this study to Assess the healing process of the immediate implant loading with two different provisional techniques (direct and indirect). Materials and methods: 20 implant in the aesthetic zone either in the incisor or in the canine area and excluding the lateral location and then immediate loading is… Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Implant Site Reaction
- What is being tested?
- Direct provisional technique and Indirect Provisional technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 19 Jan 2017to 19 Jul 2018
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- esthetic request.
- either incisor or canine indicated for extraction.
- symmetrical gingival level.
- no active periodontal disease.
- age between 20-40 years old
Who cannot join
- Lateral hopeless tooth .
- Active periodontal lesion .
- loss of periodontal tissue .
- missed incisor or missed canine in the area of implantation.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Syria2 sites
Department of Fixed Prosthodontics, University of Damsacus
Damascus, DM20AM18
Nano Physical lab and biomaterial Lab - College of Applied Sciences
Damascus
Lebanon1 site
Department of Oral Implantology -Sante Jousef University - School of Dental Medicine
Beirut
About this study
Official title: Evaluation of the Clinical Efficacy of the Immediate Implant Loading in the Aesthetic Zone
Aim: The aim of this study to Assess the healing process of the immediate implant loading with two different provisional techniques (direct and indirect).
Materials and methods:
20 implant in the aesthetic zone either in the incisor or in the canine area and excluding the lateral location and then immediate loading is achieved for the 20 implants (10 for direct and 10 for indirect method) Clinical Aspect :color change , healing and bone resorption Esthetic assessment and patient acceptance will be assessed using specific tools.
Lab aspect: surface roughness and Marginal fit will be measured to have clue vision.
Read the detailed description
Aim: The aim of this study to Assess the healing process of the immediate implant loading with two different provisional techniques (direct and indirect).
Materials and methods:
20 implant (Implant Direct ) in the aesthetic zone either in the incisor or in the canine area and excluding the lateral location and then immediate loading is achieved for the 20 implants (10 for direct and 10 for indirect method) Clinical Aspect :color change , healing and bone resorption Aesthetic assessment and patient acceptance will be assessed using specific tools Lab aspect: surface roughness and Marginal fit will be measured to have clue vision.
The participants were non-dental students from University colleges in and around Damascus. They were recruited by reviewing the case documents 20 patient with hapless incisal and canine for extraction and immediate implantation and immediate loading with either the two different provisional methods participants had to demonstrate a hopeless central incisor or canine with no perio-active infection. With two types of provisional technique we will have a two groups were calculated a priori in such a way that index can be identified with with alpha = .05 in a two-tailed test, a sample size of 2 X10 implants would result in a power of 94% (g power 3.1.3) based on a pilot study.
Cone-beam computed tomography (CBCT) images for each patient to measure the bone level change and aesthetic assessment by three general dentists will be achieved. Replica technique required the application of impression material build up of addition-silicone. Addition-silicone of very low viscosity (ExpressTM2 Ultra-Light Body Quick) was applied to all restorations interior, after which the crowns were set onto basic samples. Impression material was polymerized within the time which is recommended by the manufacturer, while the pressure force of 50 N was applied toward occlusal direction After the removal of all restorations from the basic samples, the layer of impression material remained on the restoration's inner surface due to its higher roughness compared to the abutment surface. With Rt 200 device the roughness will bw measured and then Scanning Electronic Microscope (SEM) images will give a close understanding of the surface. Easy shade will measure the color change.
- Conditions
- Implant Site Reaction
- Being tested
- Direct provisional technique, Indirect Provisional technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct provisional techniqueProcedure or surgery
The method of implantation will be accomplished directly.
Indirect Provisional techniqueProcedure or surgery
The method of implantation will be accomplished indirectly.
| Study group | Role | What they receive |
|---|---|---|
| Direct provisional technique | Experimental | Patients here will be subjected to the direct provisional technique Receives: Procedure: Direct provisional technique |
| Indirect Provisional technique | Active comparator | Patients here will be subjected to the indirect provisional technique Receives: Procedure: Indirect Provisional technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in alveolar bone level
This will be measured using cone-beam computed tomography images
Measured: T1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantation
Change in the Gingival Index
This will be measured using the the gingival index
Measured: T1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantation
Change in Esthetic Appearance
This will be measured by using the White Esthetic Scale (WES)
Measured: T1: at one day before implantation, T2: at three months following implantation
Change in the Plaque Index
This will be measured using the the plaque index
Measured: T1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantation
Change in the Pink Esthetic Scale
This will be measured using the Pink Esthetic Scale
Measured: T1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantation
Secondary outcomes (1)
Change in Restoration Color
This will be measured using a standardized color guide
Measured: T1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2017
- Study start19 Jan 2017
- Primary completion19 Jan 2018
- Study completion19 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Implant Site ReactionStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Collaborators
- St Joseph University, Beirut, Lebanon, Syrian Atomic Energy Agency, Damascus, Syria
- Responsible party
- Sponsor
- Investigators
- Anas Abdo, DDS MSc, Principal investigator, PhD student in Fixed Prosthodontics, Department of Fixed Prosthodontics, University of Damascus Dental SchoolOsama Yousuf Solieman, DDS MSc PhD, Study director, Laboratoire Bioinge Ânierie et Nanosciences EA4203, Montpellier University, Montpellier, FranceChristian Makary, DDS MSc PhD, Study director, Professor of Oral Implantology, Sante Jousef University, School of Dental Medicine, Beirut, LebanonMirza Allaf, DDS MSc PhD, Study chair, Professor of Fixed Prosthodontics, University of Damascus Dental School, Damascus, Syria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03305679
- Sponsor's protocol ID
- UDDS-FixPro-01-2017
- Status last verified
- Jul 2018
- First submitted
- 2 Oct 2017
- Last updated
- 30 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Friberg B. Bone augmentation for single tooth implants: A review of the literature. Eur J Oral Implantol. 2016;9 Suppl 1:S123-34.
PubMed 27314117Sanchez-Siles M, Munoz-Camara D, Salazar-Sanchez N, Camacho-Alonso F, Calvo-Guirado JL. Crestal bone loss around submerged and non-submerged implants during the osseointegration phase with different healing abutment designs: a randomized prospective clinical study. Clin Oral Implants Res. 2018 Jul;29(7):808-812. doi: 10.1111/clr.12981. Epub 2016 Sep 5.
PubMed 27596682Stoupel J, Lee CT, Glick J, Sanz-Miralles E, Chiuzan C, Papapanou PN. Immediate implant placement and provisionalization in the aesthetic zone using a flapless or a flap-involving approach: a randomized controlled trial. J Clin Periodontol. 2016 Dec;43(12):1171-1179. doi: 10.1111/jcpe.12610. Epub 2016 Oct 17.
PubMed 27501953Sethi A, Kaus T. Immediate Replacement of Single Teeth With Immediately Loaded Implants: Retrospective Analysis of a Clinical Case Series. Implant Dent. 2017 Feb;26(1):30-36. doi: 10.1097/ID.0000000000000512.
PubMed 27902498Zhang S, Wang S, Song Y. Immediate loading for implant restoration compared with early or conventional loading: A meta-analysis. J Craniomaxillofac Surg. 2017 Jun;45(6):793-803. doi: 10.1016/j.jcms.2016.05.002. Epub 2016 May 14.
PubMed 28351528Abdel-Azim T, Rogers K, Elathamna E, Zandinejad A, Metz M, Morton D. Comparison of the marginal fit of lithium disilicate crowns fabricated with CAD/CAM technology by using conventional impressions and two intraoral digital scanners. J Prosthet Dent. 2015 Oct;114(4):554-9. doi: 10.1016/j.prosdent.2015.04.001. Epub 2015 Jun 20.
PubMed 26100929Varol S, Kulak-Ozkan Y. In Vitro Comparison of Marginal and Internal Fit of Press-on-Metal Ceramic (PoM) Restorations with Zirconium-Supported and Conventional Metal Ceramic Fixed Partial Dentures Before and After Veneering. J Prosthodont. 2015 Jul;24(5):387-93. doi: 10.1111/jopr.12229. Epub 2014 Oct 1.
PubMed 25274041Renne W, Wolf B, Kessler R, McPherson K, Mennito AS. Evaluation of the Marginal Fit of CAD/CAM Crowns Fabricated Using Two Different Chairside CAD/CAM Systems on Preparations of Varying Quality. J Esthet Restor Dent. 2015 Jul-Aug;27(4):194-202. doi: 10.1111/jerd.12148. Epub 2015 Jul 14.
PubMed 26177118Louropoulou A, Slot DE, Van der Weijden F. Influence of mechanical instruments on the biocompatibility of titanium dental implants surfaces: a systematic review. Clin Oral Implants Res. 2015 Jul;26(7):841-50. doi: 10.1111/clr.12365. Epub 2014 Mar 19.
PubMed 24641774
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical Efficacy of the Immediate Implant Loading in the Aesthetic Zone
- ClinicalTrials.gov ID
- NCT03305679
- Acronym / sponsor ID
- UDDS-FixPro-01-2017
- Conditions
- Implant Site Reaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Collaborators
- St Joseph University, Beirut, Lebanon, Syrian Atomic Energy Agency, Damascus, Syria
- Study start
- 19 Jan 2017 (actual)
- Primary completion
- 19 Jan 2018 (actual)
- Study completion
- 19 Jul 2018 (actual)
- First posted
- 10 Oct 2017 (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.
Aim: The aim of this study to Assess the healing process of the immediate implant loading with two different provisional techniques (direct and indirect).
Materials and methods:
20 implant in the aesthetic zone either in the incisor or in the canine area and excluding the lateral location and then immediate loading is achieved for the 20 implants (10 for direct and 10 for indirect method) Clinical Aspect :color change , healing and bone resorption Esthetic assessment and patient acceptance will be assessed using specific tools.
Lab aspect: surface roughness and Marginal fit will be measured to have clue vision.
Detailed description
Aim: The aim of this study to Assess the healing process of the immediate implant loading with two different provisional techniques (direct and indirect).
Materials and methods:
20 implant (Implant Direct ) in the aesthetic zone either in the incisor or in the canine area and excluding the lateral location and then immediate loading is achieved for the 20 implants (10 for direct and 10 for indirect method) Clinical Aspect :color change , healing and bone resorption Aesthetic assessment and patient acceptance will be assessed using specific tools Lab aspect: surface roughness and Marginal fit will be measured to have clue vision.
The participants were non-dental students from University colleges in and around Damascus. They were recruited by reviewing the case documents 20 patient with hapless incisal and canine for extraction and immediate implantation and immediate loading with either the two different provisional methods participants had to demonstrate a hopeless central incisor or canine with no perio-active infection. With two types of provisional technique we will have a two groups were calculated a priori in such a way that index can be identified with with alpha = .05 in a two-tailed test, a sample size of 2 X10 implants would result in a power of 94% (g power 3.1.3) based on a pilot study.
Cone-beam computed tomography (CBCT) images for each patient to measure the bone level change and aesthetic assessment by three general dentists will be achieved. Replica technique required the application of impression material build up of addition-silicone. Addition-silicone of very low viscosity (ExpressTM2 Ultra-Light Body Quick) was applied to all restorations interior, after which the crowns were set onto basic samples. Impression material was polymerized within the time which is recommended by the manufacturer, while the pressure force of 50 N was applied toward occlusal direction After the removal of all restorations from the basic samples, the layer of impression material remained on the restoration's inner surface due to its higher roughness compared to the abutment surface. With Rt 200 device the roughness will bw measured and then Scanning Electronic Microscope (SEM) images will give a close understanding of the surface. Easy shade will measure the color change.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Direct provisional technique | Experimental | Procedure: Direct provisional techniquePatients here will be subjected to the direct provisional technique |
| Indirect Provisional technique | Active comparator | Procedure: Indirect Provisional techniquePatients here will be subjected to the indirect provisional technique |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- esthetic request.
- either incisor or canine indicated for extraction.
- symmetrical gingival level.
- no active periodontal disease.
- age between 20-40 years old
Key exclusion criteria (4 listed)
- Lateral hopeless tooth .
- Active periodontal lesion .
- loss of periodontal tissue .
- missed incisor or missed canine in the area of implantation.
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 |
|---|---|---|
| Direct provisional techniqueThe method of implantation will be accomplished directly. | Procedure or surgery | Direct provisional technique |
| Indirect Provisional techniqueThe method of implantation will be accomplished indirectly. | Procedure or surgery | Indirect Provisional technique |
Primary outcome
Change in alveolar bone level
Time frame: T1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantation
This will be measured using cone-beam computed tomography images
Change in the Gingival Index
Time frame: T1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantation
This will be measured using the the gingival index
Change in Esthetic Appearance
Time frame: T1: at one day before implantation, T2: at three months following implantation
This will be measured by using the White Esthetic Scale (WES)
Change in the Plaque Index
Time frame: T1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantation
This will be measured using the the plaque index
Change in the Pink Esthetic Scale
Time frame: T1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantation
This will be measured using the Pink Esthetic Scale
1 secondary outcome
Change in Restoration Color
Time frame: T1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2018.
- Background: PubMed 27314117Friberg B. Bone augmentation for single tooth implants: A review of the literature. Eur J Oral Implantol. 2016;9 Suppl 1:S123-34.
- Background: PubMed 27596682Sanchez-Siles M, Munoz-Camara D, Salazar-Sanchez N, Camacho-Alonso F, Calvo-Guirado JL. Crestal bone loss around submerged and non-submerged implants during the osseointegration phase with different healing abutment designs: a randomized prospective clinical study. Clin Oral Implants Res. 2018 Jul;29(7):808-812. doi: 10.1111/clr.12981. Epub 2016 Sep 5.
- Background: PubMed 27501953Stoupel J, Lee CT, Glick J, Sanz-Miralles E, Chiuzan C, Papapanou PN. Immediate implant placement and provisionalization in the aesthetic zone using a flapless or a flap-involving approach: a randomized controlled trial. J Clin Periodontol. 2016 Dec;43(12):1171-1179. doi: 10.1111/jcpe.12610. Epub 2016 Oct 17.
- Background: PubMed 27902498Sethi A, Kaus T. Immediate Replacement of Single Teeth With Immediately Loaded Implants: Retrospective Analysis of a Clinical Case Series. Implant Dent. 2017 Feb;26(1):30-36. doi: 10.1097/ID.0000000000000512.
- Background: PubMed 28351528Zhang S, Wang S, Song Y. Immediate loading for implant restoration compared with early or conventional loading: A meta-analysis. J Craniomaxillofac Surg. 2017 Jun;45(6):793-803. doi: 10.1016/j.jcms.2016.05.002. Epub 2016 May 14.
- Background: PubMed 26100929Abdel-Azim T, Rogers K, Elathamna E, Zandinejad A, Metz M, Morton D. Comparison of the marginal fit of lithium disilicate crowns fabricated with CAD/CAM technology by using conventional impressions and two intraoral digital scanners. J Prosthet Dent. 2015 Oct;114(4):554-9. doi: 10.1016/j.prosdent.2015.04.001. Epub 2015 Jun 20.
- Background: PubMed 25274041Varol S, Kulak-Ozkan Y. In Vitro Comparison of Marginal and Internal Fit of Press-on-Metal Ceramic (PoM) Restorations with Zirconium-Supported and Conventional Metal Ceramic Fixed Partial Dentures Before and After Veneering. J Prosthodont. 2015 Jul;24(5):387-93. doi: 10.1111/jopr.12229. Epub 2014 Oct 1.
- Background: PubMed 26177118Renne W, Wolf B, Kessler R, McPherson K, Mennito AS. Evaluation of the Marginal Fit of CAD/CAM Crowns Fabricated Using Two Different Chairside CAD/CAM Systems on Preparations of Varying Quality. J Esthet Restor Dent. 2015 Jul-Aug;27(4):194-202. doi: 10.1111/jerd.12148. Epub 2015 Jul 14.
- Background: PubMed 24641774Louropoulou A, Slot DE, Van der Weijden F. Influence of mechanical instruments on the biocompatibility of titanium dental implants surfaces: a systematic review. Clin Oral Implants Res. 2015 Jul;26(7):841-50. doi: 10.1111/clr.12365. Epub 2014 Mar 19.
- Individual participant dataSharing planned: No
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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.
Anas Abdo, DDS MSc principal investigator
PhD student in Fixed Prosthodontics, Department of Fixed Prosthodontics, University of Damascus Dental School
Osama Yousuf Solieman, DDS MSc PhD study director
Laboratoire Bioinge Ânierie et Nanosciences EA4203, Montpellier University, Montpellier, France
Christian Makary, DDS MSc PhD study director
Professor of Oral Implantology, Sante Jousef University, School of Dental Medicine, Beirut, Lebanon
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct provisional technique and Indirect Provisional technique in people with Implant Site Reaction, run by Damascus University at 3 sites in 2 countries.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 30 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Syria, Lebanon. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in alveolar bone level (time frame: T1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantation). The study lists 5 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 NCT03305679, which also lists 9 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 30 Jul 2018.