Dental ImplantNCT02309125
Comparing the Secondary Stability of Dental Implants: Immediate Gradual Loading Versus Early Loading Protocol in Posterior Maxilla
A study testing immediate progressive loading using gingival formers and submerged healing in people with Dental Implant and Transmucosal Healing, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this split mouth study is to compare which method is better in reducing bone loss and healing times following implants. Specifically, the two methods investigated will be immediate gradual loading and early loading protocol. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implant, Transmucosal Healing, Bone Loss
- What is being tested?
- immediate progressive loading using gingival formers and submerged healing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2014to Apr 2015
- 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 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with bilateral Partial or complete edentulous areas in maxillary premolar/molar region.
- Free medical history.
- Enough bone quantity.
- Enough keratinized mucosa
Who cannot join
- Systemic disease.
- Irradiated bone (radiotherapy).
- Heavy smoking habit.
- Patients undergoing long-term immunosuppressive therapy.
- Atrophic ridges.
- Presence of any local bony lesion.
- Presence of mandibular parafunctional habits
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of oral & Dental Medicine. Cairo University
Cairo
Elhassan Mossad, oral surgeon, 00201111113770, mossadelhassan@yahoo.com
Mohamed kashaba, lecturer (PHD), 00201227754765
About this study
Official title: Split Mouth Clinical Study to Compare the Secondary Stability of Dental Implants Using Immediate Gradual Loading Versus Early Loading Protocol in Posterior Maxilla. A Randomized Controlled Trial
The aim of this split mouth study is to compare which method is better in reducing bone loss and healing times following implants. Specifically, the two methods investigated will be immediate gradual loading and early loading protocol.
Research Hypothesis Immediate gradual loading using gingival formers is superior to early loading protocols in improving bone quality and thus reducing the healing time.
Read the detailed description
These two methods (gradual loading and early loading) will both be used in implants patients with the aim to compare which protocol leads to a better outcome for the patient.
A 'better outcome' is defined as the method, which leads to the least crestal bone loss, and the fastest healing time.
Immediate gradually loaded side: will include transmucosal healing of dental implants using gingival formers which will be replaced every 2 weeks by consequent larger size gingival former.i.e. at surgery time the implants will receive 2 mm height gingival former which will be swapped by 3 mm, 4 mm, 5 mm and the last is 6 mm
early loaded side: implants will be submerged from the surgery time till loading time (2 month).
- Conditions
- Dental Implant, Transmucosal Healing, Bone Loss
- Being tested
- immediate progressive loading using gingival formers, submerged healing
- Keywords
- immediate gradual loading
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immediate progressive loading using gingival formersProcedure or surgery
Implant placement will be 1 mm subcrestally, and it will receive transmucosal healing using gingival former.
The gingival former will be replaced every 2 weeks by consequent larger size gingival former (at surgery time group A will receive 2 mm height gingival former which will be swapped by,3 mm, 4 mm and the last is 5 mm).
submerged healingProcedure or surgery
the implant placement will be 1 mm subcrestally, and it will receive unloaded healing.(submerged healing)
| Study group | Role | What they receive |
|---|---|---|
| implant A | Experimental | will include implants with immediate progressive loading using gingival formers of different sizes Receives: Procedure: immediate progressive loading using gingival formers |
| implant B | Other | The implants will remain submerged from surgery time till loading time 2 month.(submerged healing) Receives: Procedure: submerged healing |
What is being measured
The primary outcome is the main question the study is designed to answer.
secondary stability of dental implant (ISQ Osstell Mentol)
ISQ Osstell Mentol
Measured: 2 month
Secondary outcomes (1)
Bone loss using Periapical Radiographic (Long Cone Paralleling technique)
using Periapical Radiographic (Long Cone Paralleling technique)
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionMar 2015 (estimated)
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Dental ImplantStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elhassan Mohamed Elsayed Mostafa Mossad, Cairo University
- Investigators
- elhassan mossad, oral surgeon, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02309125
- Sponsor's protocol ID
- immediate_early_loading
- Status last verified
- Nov 2014
- First submitted
- 3 Dec 2014
- Last updated
- 5 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Appleton RS, Nummikoski PV, Pigno MA, Cronin RJ, Chung KH. A radiographic assessment of progressive loading on bone around single osseointegrated implants in the posterior maxilla. Clin Oral Implants Res. 2005 Apr;16(2):161-7. doi: 10.1111/j.1600-0501.2004.01089.x.
PubMed 15777325Attard NJ, Zarb GA. Immediate and early implant loading protocols: a literature review of clinical studies. J Prosthet Dent. 2005 Sep;94(3):242-58. doi: 10.1016/j.prosdent.2005.04.015.
PubMed 16126077Berglundh T, Abrahamsson I, Lindhe J. Bone reactions to longstanding functional load at implants: an experimental study in dogs. J Clin Periodontol. 2005 Sep;32(9):925-32. doi: 10.1111/j.1600-051X.2005.00747.x.
PubMed 16104954Buchter A, Wiechmann D, Koerdt S, Wiesmann HP, Piffko J, Meyer U. Load-related implant reaction of mini-implants used for orthodontic anchorage. Clin Oral Implants Res. 2005 Aug;16(4):473-9. doi: 10.1111/j.1600-0501.2005.01149.x.
PubMed 16117773Duyck J, Vandamme K, Geris L, Van Oosterwyck H, De Cooman M, Vandersloten J, Puers R, Naert I. The influence of micro-motion on the tissue differentiation around immediately loaded cylindrical turned titanium implants. Arch Oral Biol. 2006 Jan;51(1):1-9. doi: 10.1016/j.archoralbio.2005.04.003. Epub 2005 May 31.
PubMed 15922992Duyck J, Vrielinck L, Lambrichts I, Abe Y, Schepers S, Politis C, Naert I. Biologic response of immediately versus delayed loaded implants supporting ill-fitting prostheses: an animal study. Clin Implant Dent Relat Res. 2005;7(3):150-8. doi: 10.1111/j.1708-8208.2005.tb00059.x.
PubMed 16219245Ghoveizi R, Alikhasi M, Siadat MR, Siadat H, Sorouri M. A radiographic comparison of progressive and conventional loading on crestal bone loss and density in single dental implants: a randomized controlled trial study. J Dent (Tehran). 2013 Mar;10(2):155-63. Epub 2013 Mar 31.
PubMed 23724215Isidor F. Mobility assessment with the Periotest system in relation to histologic findings of oral implants. Int J Oral Maxillofac Implants. 1998 May-Jun;13(3):377-83.
PubMed 9638008Piattelli A, Corigliano M, Scarano A, Costigliola G, Paolantonio M. Immediate loading of titanium plasma-sprayed implants: an histologic analysis in monkeys. J Periodontol. 1998 Mar;69(3):321-7. doi: 10.1902/jop.1998.69.3.321.
PubMed 9579618Piattelli A, Scarano A, Piattelli M, Bertolai R, Panzoni E. Histologic aspects of the bone and soft tissues surrounding three titanium non-submerged plasma-sprayed implants retrieved at autopsy: a case report. J Periodontol. 1997 Jul;68(7):694-700. doi: 10.1902/jop.1997.68.7.694.
PubMed 9249642Soballe K, Hansen ES, Brockstedt-Rasmussen H, Hjortdal VE, Juhl GI, Pedersen CM, Hvid I, Bunger C. Gap healing enhanced by hydroxyapatite coating in dogs. Clin Orthop Relat Res. 1991 Nov;(272):300-7.
PubMed 1657476Szmukler-Moncler S, Piattelli A, Favero GA, Dubruille JH. Considerations preliminary to the application of early and immediate loading protocols in dental implantology. Clin Oral Implants Res. 2000 Feb;11(1):12-25. doi: 10.1034/j.1600-0501.2000.011001012.x.
PubMed 11168189Frost HM. Perspectives: bone's mechanical usage windows. Bone Miner. 1992 Dec;19(3):257-71. doi: 10.1016/0169-6009(92)90875-e.
PubMed 1472896Frost HM. A 2003 update of bone physiology and Wolff's Law for clinicians. Angle Orthod. 2004 Feb;74(1):3-15. doi: 10.1043/0003-3219(2004)0742.0.CO;2.
PubMed 15038485Misch CE, Hoar J, Beck G, Hazen R, Misch CM. A bone quality-based implant system: a preliminary report of stage I & stage II. Implant Dent. 1998;7(1):35-42. doi: 10.1097/00008505-199804000-00004.
PubMed 9588972
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Split Mouth Clinical Study to Compare the Secondary Stability of Dental Implants Using Immediate Gradual Loading Versus Early Loading Protocol in Posterior Maxilla. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02309125
- Acronym / sponsor ID
- immediate_early_loading
- Conditions
- Dental Implant, Transmucosal Healing, Bone Loss
- Keywords
- immediate gradual loading
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 5 Dec 2014 (estimated)
- 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.
The aim of this split mouth study is to compare which method is better in reducing bone loss and healing times following implants. Specifically, the two methods investigated will be immediate gradual loading and early loading protocol.
Research Hypothesis Immediate gradual loading using gingival formers is superior to early loading protocols in improving bone quality and thus reducing the healing time.
Detailed description
These two methods (gradual loading and early loading) will both be used in implants patients with the aim to compare which protocol leads to a better outcome for the patient.
A 'better outcome' is defined as the method, which leads to the least crestal bone loss, and the fastest healing time.
Immediate gradually loaded side: will include transmucosal healing of dental implants using gingival formers which will be replaced every 2 weeks by consequent larger size gingival former.i.e. at surgery time the implants will receive 2 mm height gingival former which will be swapped by 3 mm, 4 mm, 5 mm and the last is 6 mm
early loaded side: implants will be submerged from the surgery time till loading time (2 month).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| implant A | Experimental | Procedure: immediate progressive loading using gingival formerswill include implants with immediate progressive loading using gingival formers of different sizes |
| implant B | Other | Procedure: submerged healingThe implants will remain submerged from surgery time till loading time 2 month.(submerged healing) |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with bilateral Partial or complete edentulous areas in maxillary premolar/molar region.
- Free medical history.
- Enough bone quantity.
- Enough keratinized mucosa
Key exclusion criteria (7 listed)
- Systemic disease.
- Irradiated bone (radiotherapy).
- Heavy smoking habit.
- Patients undergoing long-term immunosuppressive therapy.
- Atrophic ridges.
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 |
|---|---|---|
| immediate progressive loading using gingival formersImplant placement will be 1 mm subcrestally, and it will receive transmucosal healing using gingival former. The gingival former will be replaced every 2 weeks by consequent larger size gingival former (at surgery time group A will receive 2 mm height gingival former which will be swapped by,3 mm, 4 mm and the last is 5 mm). | Procedure or surgery | implant A |
| submerged healingthe implant placement will be 1 mm subcrestally, and it will receive unloaded healing.(submerged healing) | Procedure or surgery | implant B |
Primary outcome
secondary stability of dental implant (ISQ Osstell Mentol)
Time frame: 2 month
ISQ Osstell Mentol
1 secondary outcome
Bone loss using Periapical Radiographic (Long Cone Paralleling technique)
Time frame: 2 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2014.
- Background: PubMed 15777325Appleton RS, Nummikoski PV, Pigno MA, Cronin RJ, Chung KH. A radiographic assessment of progressive loading on bone around single osseointegrated implants in the posterior maxilla. Clin Oral Implants Res. 2005 Apr;16(2):161-7. doi: 10.1111/j.1600-0501.2004.01089.x.
- Background: PubMed 16126077Attard NJ, Zarb GA. Immediate and early implant loading protocols: a literature review of clinical studies. J Prosthet Dent. 2005 Sep;94(3):242-58. doi: 10.1016/j.prosdent.2005.04.015.
- Background: PubMed 16104954Berglundh T, Abrahamsson I, Lindhe J. Bone reactions to longstanding functional load at implants: an experimental study in dogs. J Clin Periodontol. 2005 Sep;32(9):925-32. doi: 10.1111/j.1600-051X.2005.00747.x.
- Background: PubMed 16117773Buchter A, Wiechmann D, Koerdt S, Wiesmann HP, Piffko J, Meyer U. Load-related implant reaction of mini-implants used for orthodontic anchorage. Clin Oral Implants Res. 2005 Aug;16(4):473-9. doi: 10.1111/j.1600-0501.2005.01149.x.
- Background: PubMed 15922992Duyck J, Vandamme K, Geris L, Van Oosterwyck H, De Cooman M, Vandersloten J, Puers R, Naert I. The influence of micro-motion on the tissue differentiation around immediately loaded cylindrical turned titanium implants. Arch Oral Biol. 2006 Jan;51(1):1-9. doi: 10.1016/j.archoralbio.2005.04.003. Epub 2005 May 31.
- Background: PubMed 16219245Duyck J, Vrielinck L, Lambrichts I, Abe Y, Schepers S, Politis C, Naert I. Biologic response of immediately versus delayed loaded implants supporting ill-fitting prostheses: an animal study. Clin Implant Dent Relat Res. 2005;7(3):150-8. doi: 10.1111/j.1708-8208.2005.tb00059.x.
- Background: PubMed 23724215Ghoveizi R, Alikhasi M, Siadat MR, Siadat H, Sorouri M. A radiographic comparison of progressive and conventional loading on crestal bone loss and density in single dental implants: a randomized controlled trial study. J Dent (Tehran). 2013 Mar;10(2):155-63. Epub 2013 Mar 31.
- Background: PubMed 9638008Isidor F. Mobility assessment with the Periotest system in relation to histologic findings of oral implants. Int J Oral Maxillofac Implants. 1998 May-Jun;13(3):377-83.
- Background: PubMed 9579618Piattelli A, Corigliano M, Scarano A, Costigliola G, Paolantonio M. Immediate loading of titanium plasma-sprayed implants: an histologic analysis in monkeys. J Periodontol. 1998 Mar;69(3):321-7. doi: 10.1902/jop.1998.69.3.321.
- Background: PubMed 9249642Piattelli A, Scarano A, Piattelli M, Bertolai R, Panzoni E. Histologic aspects of the bone and soft tissues surrounding three titanium non-submerged plasma-sprayed implants retrieved at autopsy: a case report. J Periodontol. 1997 Jul;68(7):694-700. doi: 10.1902/jop.1997.68.7.694.
- Background: PubMed 1657476Soballe K, Hansen ES, Brockstedt-Rasmussen H, Hjortdal VE, Juhl GI, Pedersen CM, Hvid I, Bunger C. Gap healing enhanced by hydroxyapatite coating in dogs. Clin Orthop Relat Res. 1991 Nov;(272):300-7.
- Background: PubMed 11168189Szmukler-Moncler S, Piattelli A, Favero GA, Dubruille JH. Considerations preliminary to the application of early and immediate loading protocols in dental implantology. Clin Oral Implants Res. 2000 Feb;11(1):12-25. doi: 10.1034/j.1600-0501.2000.011001012.x.
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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.
elhassan mossad, oral surgeon principal investigator
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 immediate progressive loading using gingival formers and submerged healing in people with Dental Implant and Transmucosal Healing, 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 4 inclusion and 7 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 5 Dec 2014. 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 elhassan mossad, oral surgeon (+201111113770, mossadelhassan@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
secondary stability of dental implant (ISQ Osstell Mentol) (time frame: 2 month). 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 NCT02309125, which also lists 21 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 5 Dec 2014.