Broken TeethNCT04436094
Soft Tissue Outcomes Of Badly Broken-Down Teeth Treated With Orthodontic Extrusion Compared With Immediate Implant Placement
A study testing Orthodontic extrusion and Immediate implant placement in people with Broken Teeth, run by Cairo University.
Trial summary
Many patients suffer from tooth substance loss as a result of fracture or decay of teeth situated in the esthetic zone. This might commonly occur with car accidents, sport injuries, falls or even fistfights. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Broken Teeth
- What is being tested?
- Orthodontic extrusion and Immediate implant placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Sep 2020to Sep 2021
- 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
- Patients at 20-40 years old and have no history of periodontal disease. (periodontally healthy patients).
- Single rooted teeth with adjacent intact or restored neighboring teeth, more than one tooth may be included in the same arch.
- More than 1:1 crown root ratio, so that the C/R is 1:1 after extrusion and restoration.
- Presence of intact adjacent teeth.
Who cannot join
- Badly broken-down teeth with active signs of infection.
- Teeth with vertical root fracture.
- Teeth with severely tapered roots..
- Diabetic patients, assessed by measuring glycosylated hemoglobin (HbA1c). Patients with an HbA1c level greater than 8 will be excluded.
- Potentially uncooperative patients who are not willing to go through the proposed interventions (patients who will refuse to undergo orthodontic treatment).
- Moderate-to-heavy daily smokers* (who report consuming at least 11 cigarettes/day).
Show all 11Show fewer
- Patients with systemic disease that may affect normal healing.
- Psychiatric problems, emotional instability, and unrealistic esthetic demands.
- History of radiation therapy to the head and neck, or bone augmentation to implant site.
- Labial cortical bone fenestration diagnosed from CBCT.
- Bruxism.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Soft Tissue Outcomes Of Badly Broken-Down Teeth Treated With Orthodontic Extrusion Compared With Immediate Implant Placement: A Randomized Controlled Trial
Many patients suffer from tooth substance loss as a result of fracture or decay of teeth situated in the esthetic zone. This might commonly occur with car accidents, sport injuries, falls or even fistfights.
For those patients, most of the crown is lost and only the root remains, so there is no enough ferrule in order to restore the tooth with a crown.
Read more
The most common treatment for those patients is immediate single-tooth implant. However, some problems may arise such as: high treatment expenses, the need for bone augmentation, the refill of the papilla to its normal position may be questionable in some implant cases, young growing patients, apprehensive patients, dental facilities and rural areas lacking cone beam computed tomography (CBCT) machines.
Accordingly, orthodontic extrusion may be an alternative attempt to preserve the tooth by traction of the remaining root to create a sufficient ferrule effect to restore the tooth.
- Conditions
- Broken Teeth
- Being tested
- Orthodontic extrusion, Immediate implant placement
- Medical subject headings
- Tooth Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthodontic extrusionProcedure or surgery
An orthodontic attachment will be bonded to the core of the experimental tooth. Orthodontic brackets "American Orthodontics Roth prescription. 0.022" slot" will be bonded to the adjacent teeth. A passive rectangular stainless steel wire (0.016X0.022") will be inserted in the adjacent teeth with a step down and a coil at the site of the experimental tooth.
Orthodontic extrusion will start using a light overlay wire of 0.012" NiTi and then continued by elastic chains/ threads extending between the attachment on the tooth and the stabilizing wire. The patient is followed up for appliance activation every 3-4 weeks and extrusion is performed until an adequate ferrule effect of 2 mm is present all around the tooth circumference (in addition to the biologic width). So the extrusion is completed when the tooth is 4-4.5 mm from the alveolar bone crest as judged by periapical radiographs.
Immediate implant placementProcedure or surgery
The patient is anaesthetized. Atraumatic extraction of the badly broken down teeth will be performed using peroiotome. Luxation should be done mesiodistally and not buccolingually, to avoid damaging the buccal plate. After tooth removal, a curette is used to confirm that the location of the buccal plate is intact. Standard drilling procedures are performed according to the manufacturer's instructions. Then the implant is placed in the prepared site. Temporization should be done using composite 3M Filtek Z250 XT material. Finally, a porcelain fused to zirconia crown will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Orthodontic extrusion | Experimental | An orthodontic attachment will be bonded to the core of the experimental tooth. Orthodontic brackets "American Orthodontics Roth prescription. 0.022" slot" will be bonded to the adjacent teeth. A passive rectangular stainless steel wire (0.016X0.022") will be inserted in the adjacent teeth with a step down and a coil at the site of the experimental tooth.
Orthodontic extrusion will start using a light overlay wire of 0.012" NiTi and then continued by elastic chains/ threads extending between the attachment on the tooth and the stabilizing wire. The patient is followed up for appliance activation every 3-4 weeks and extrusion is performed until an adequate ferrule effect of 2 mm is present all around the tooth circumference (in addition to the biologic width). So the extrusion is completed when the tooth is 4-4.5 mm from the alveolar bone crest as judged by periapical radiographs. Receives: Procedure: Orthodontic extrusion |
| Immediate implant placement | Active comparator | The patient is anaesthetized. Atraumatic extraction of the badly broken down teeth will be performed using peroiotome. Luxation should be done mesiodistally and not buccolingually, to avoid damaging the buccal plate. After tooth removal, a curette is used to confirm that the location of the buccal plate is intact. Standard drilling procedures are performed according to the manufacturer's instructions. Then the implant is placed in the prepared site. Temporization should be done using composite 3M Filtek Z250 XT material. Finally, a porcelain fused to zirconia crown will be performed. Receives: Procedure: Immediate implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Soft tissue outcome
Pink esthetic score: 0-1-2 scoring system, 0 being the lowest, 2 being the highest value
Measured: 12 months
Secondary outcomes (1)
Survival
Tooth and Implant survival
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study startSep 2020 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Broken 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moustafa Osama Shehata, Cairo University
- Investigators
- Moustafa O Shehata, B.D.S., Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04436094
- Sponsor's protocol ID
- 22042020
- Status last verified
- Jun 2020
- First submitted
- 15 Jun 2020
- Last updated
- 17 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Bastone EB, Freer TJ, McNamara JR. Epidemiology of dental trauma: a review of the literature. Aust Dent J. 2000 Mar;45(1):2-9. doi: 10.1111/j.1834-7819.2000.tb00234.x.
PubMed 10846265Juloski J, Radovic I, Goracci C, Vulicevic ZR, Ferrari M. Ferrule effect: a literature review. J Endod. 2012 Jan;38(1):11-9. doi: 10.1016/j.joen.2011.09.024. Epub 2011 Nov 13.
PubMed 22152612Olsburgh S, Jacoby T, Krejci I. Crown fractures in the permanent dentition: pulpal and restorative considerations. Dent Traumatol. 2002 Jun;18(3):103-15. doi: 10.1034/j.1600-9657.2002.00004.x.
PubMed 12110103Rosenberg ES, Cho SC, Garber DA. Crown lengthening revisited. Compend Contin Educ Dent. 1999 Jun;20(6):527-32, 534, 536-8 passim; quiz 542.
PubMed 10650366Grossmann Y, Sadan A. The prosthodontic concept of crown-to-root ratio: a review of the literature. J Prosthet Dent. 2005 Jun;93(6):559-62. doi: 10.1016/j.prosdent.2005.03.006.
PubMed 15942617Alsahhaf A, Att W. Orthodontic extrusion for pre-implant site enhancement: Principles and clinical guidelines. J Prosthodont Res. 2016 Jul;60(3):145-55. doi: 10.1016/j.jpor.2016.02.004. Epub 2016 Mar 12.
PubMed 26979626Elkhadem A, Mickan S, Richards D. Adverse events of surgical extrusion in treatment for crown-root and cervical root fractures: a systematic review of case series/reports. Dent Traumatol. 2014 Feb;30(1):1-14. doi: 10.1111/edt.12051. Epub 2013 Jun 25.
PubMed 23796195Yuan LT, Duan DM, Tan L, Wang XJ, Wu LA. Treatment for a complicated crown-root fracture with intentional replantation: a case report with a 3.5-year follow up. Dent Traumatol. 2013 Dec;29(6):474-8. doi: 10.1111/j.1600-9657.2012.01130.x. Epub 2012 Mar 27.
PubMed 22453056Malmgren O, Malmgren B, Frykholm A. Rapid orthodontic extrusion of crown root and cervical root fractured teeth. Endod Dent Traumatol. 1991 Apr;7(2):49-54. doi: 10.1111/j.1600-9657.1991.tb00183.x.
PubMed 1782893Schwartz-Arad D, Chaushu G. Placement of implants into fresh extraction sites: 4 to 7 years retrospective evaluation of 95 immediate implants. J Periodontol. 1997 Nov;68(11):1110-6. doi: 10.1902/jop.1997.68.11.1110.
PubMed 9407405Furhauser R, Florescu D, Benesch T, Haas R, Mailath G, Watzek G. Evaluation of soft tissue around single-tooth implant crowns: the pink esthetic score. Clin Oral Implants Res. 2005 Dec;16(6):639-44. doi: 10.1111/j.1600-0501.2005.01193.x.
PubMed 16307569Albrektsson 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 3527955Smith DE, Zarb GA. Criteria for success of osseointegrated endosseous implants. J Prosthet Dent. 1989 Nov;62(5):567-72. doi: 10.1016/0022-3913(89)90081-4.
PubMed 2691661Albrektsson T, Zarb GA. Determinants of correct clinical reporting. Int J Prosthodont. 1998 Sep-Oct;11(5):517-21. No abstract available.
PubMed 9922743Misch CE, Perel ML, Wang HL, Sammartino G, Galindo-Moreno P, Trisi P, Steigmann M, Rebaudi A, Palti A, Pikos MA, Schwartz-Arad D, Choukroun J, Gutierrez-Perez JL, Marenzi G, Valavanis DK. Implant success, survival, and failure: the International Congress of Oral Implantologists (ICOI) Pisa Consensus Conference. Implant Dent. 2008 Mar;17(1):5-15. doi: 10.1097/ID.0b013e3181676059.
PubMed 18332753
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soft Tissue Outcomes Of Badly Broken-Down Teeth Treated With Orthodontic Extrusion Compared With Immediate Implant Placement: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04436094
- Acronym / sponsor ID
- 22042020
- Conditions
- Broken Teeth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2020 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 17 Jun 2020 (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.
Many patients suffer from tooth substance loss as a result of fracture or decay of teeth situated in the esthetic zone. This might commonly occur with car accidents, sport injuries, falls or even fistfights.
For those patients, most of the crown is lost and only the root remains, so there is no enough ferrule in order to restore the tooth with a crown.
The most common treatment for those patients is immediate single-tooth implant. However, some problems may arise such as: high treatment expenses, the need for bone augmentation, the refill of the papilla to its normal position may be questionable in some implant cases, young growing patients, apprehensive patients, dental facilities and rural areas lacking cone beam computed tomography (CBCT) machines.
Accordingly, orthodontic extrusion may be an alternative attempt to preserve the tooth by traction of the remaining root to create a sufficient ferrule effect to restore the tooth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orthodontic extrusion | Experimental | Procedure: Orthodontic extrusionAn orthodontic attachment will be bonded to the core of the experimental tooth. Orthodontic brackets "American Orthodontics Roth prescription. 0.022" slot" will be bonded to the adjacent teeth. A passive rectangular stainless steel wire (0.016X0.022") will be inserted in the adjacent teeth with a step down and a coil at the site of the experimental tooth. Orthodontic extrusion will start using a light overlay wire of 0.012" NiTi and then continued by elastic chains/ threads extending between the attachment on the tooth and the stabilizing wire. The patient is followed up for appliance activation every 3-4 weeks and extrusion is performed until an adequate ferrule effect of 2 mm is present all around the tooth circumference (in addition to the biologic width). So the extrusion is completed when the tooth is 4-4.5 mm from the alveolar bone crest as judged by periapical radiographs. |
| Immediate implant placement | Active comparator | Procedure: Immediate implant placementThe patient is anaesthetized. Atraumatic extraction of the badly broken down teeth will be performed using peroiotome. Luxation should be done mesiodistally and not buccolingually, to avoid damaging the buccal plate. After tooth removal, a curette is used to confirm that the location of the buccal plate is intact. Standard drilling procedures are performed according to the manufacturer's instructions. Then the implant is placed in the prepared site. Temporization should be done using composite 3M Filtek Z250 XT material. Finally, a porcelain fused to zirconia crown will be performed. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients at 20-40 years old and have no history of periodontal disease. (periodontally healthy patients).
- Single rooted teeth with adjacent intact or restored neighboring teeth, more than one tooth may be included in the same arch.
- More than 1:1 crown root ratio, so that the C/R is 1:1 after extrusion and restoration.
- Presence of intact adjacent teeth.
Key exclusion criteria (11 listed)
- Badly broken-down teeth with active signs of infection.
- Teeth with vertical root fracture.
- Teeth with severely tapered roots..
- Diabetic patients, assessed by measuring glycosylated hemoglobin (HbA1c). Patients with an HbA1c level greater than 8 will be excluded.
- Potentially uncooperative patients who are not willing to go through the proposed interventions (patients who will refuse to undergo orthodontic treatment).
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 |
|---|---|---|
| Orthodontic extrusionAn orthodontic attachment will be bonded to the core of the experimental tooth. Orthodontic brackets "American Orthodontics Roth prescription. 0.022" slot" will be bonded to the adjacent teeth. A passive rectangular stainless steel wire (0.016X0.022") will be inserted in the adjacent teeth with a step down and a coil at the site of the experimental tooth. Orthodontic extrusion will start using a light overlay wire of 0.012" NiTi and then continued by elastic chains/ threads extending between the attachment on the tooth and the stabilizing wire. The patient is followed up for appliance activation every 3-4 weeks and extrusion is performed until an adequate ferrule effect of 2 mm is present all around the tooth circumference (in addition to the biologic width). So the extrusion is completed when the tooth is 4-4.5 mm from the alveolar bone crest as judged by periapical radiographs. | Procedure or surgery | Orthodontic extrusion |
| Immediate implant placementThe patient is anaesthetized. Atraumatic extraction of the badly broken down teeth will be performed using peroiotome. Luxation should be done mesiodistally and not buccolingually, to avoid damaging the buccal plate. After tooth removal, a curette is used to confirm that the location of the buccal plate is intact. Standard drilling procedures are performed according to the manufacturer's instructions. Then the implant is placed in the prepared site. Temporization should be done using composite 3M Filtek Z250 XT material. Finally, a porcelain fused to zirconia crown will be performed. | Procedure or surgery | Immediate implant placement |
Primary outcome
Soft tissue outcome
Time frame: 12 months
Pink esthetic score: 0-1-2 scoring system, 0 being the lowest, 2 being the highest value
1 secondary outcome
Survival
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2020.
- Background: PubMed 10846265Bastone EB, Freer TJ, McNamara JR. Epidemiology of dental trauma: a review of the literature. Aust Dent J. 2000 Mar;45(1):2-9. doi: 10.1111/j.1834-7819.2000.tb00234.x.
- Background: PubMed 22152612Juloski J, Radovic I, Goracci C, Vulicevic ZR, Ferrari M. Ferrule effect: a literature review. J Endod. 2012 Jan;38(1):11-9. doi: 10.1016/j.joen.2011.09.024. Epub 2011 Nov 13.
- Background: PubMed 12110103Olsburgh S, Jacoby T, Krejci I. Crown fractures in the permanent dentition: pulpal and restorative considerations. Dent Traumatol. 2002 Jun;18(3):103-15. doi: 10.1034/j.1600-9657.2002.00004.x.
- Background: PubMed 10650366Rosenberg ES, Cho SC, Garber DA. Crown lengthening revisited. Compend Contin Educ Dent. 1999 Jun;20(6):527-32, 534, 536-8 passim; quiz 542.
- Background: PubMed 15942617Grossmann Y, Sadan A. The prosthodontic concept of crown-to-root ratio: a review of the literature. J Prosthet Dent. 2005 Jun;93(6):559-62. doi: 10.1016/j.prosdent.2005.03.006.
- Background: PubMed 26979626Alsahhaf A, Att W. Orthodontic extrusion for pre-implant site enhancement: Principles and clinical guidelines. J Prosthodont Res. 2016 Jul;60(3):145-55. doi: 10.1016/j.jpor.2016.02.004. Epub 2016 Mar 12.
- Background: PubMed 23796195Elkhadem A, Mickan S, Richards D. Adverse events of surgical extrusion in treatment for crown-root and cervical root fractures: a systematic review of case series/reports. Dent Traumatol. 2014 Feb;30(1):1-14. doi: 10.1111/edt.12051. Epub 2013 Jun 25.
- Background: PubMed 22453056Yuan LT, Duan DM, Tan L, Wang XJ, Wu LA. Treatment for a complicated crown-root fracture with intentional replantation: a case report with a 3.5-year follow up. Dent Traumatol. 2013 Dec;29(6):474-8. doi: 10.1111/j.1600-9657.2012.01130.x. Epub 2012 Mar 27.
- Background: PubMed 1782893Malmgren O, Malmgren B, Frykholm A. Rapid orthodontic extrusion of crown root and cervical root fractured teeth. Endod Dent Traumatol. 1991 Apr;7(2):49-54. doi: 10.1111/j.1600-9657.1991.tb00183.x.
- Background: PubMed 9407405Schwartz-Arad D, Chaushu G. Placement of implants into fresh extraction sites: 4 to 7 years retrospective evaluation of 95 immediate implants. J Periodontol. 1997 Nov;68(11):1110-6. doi: 10.1902/jop.1997.68.11.1110.
- Background: PubMed 16307569Furhauser R, Florescu D, Benesch T, Haas R, Mailath G, Watzek G. Evaluation of soft tissue around single-tooth implant crowns: the pink esthetic score. Clin Oral Implants Res. 2005 Dec;16(6):639-44. doi: 10.1111/j.1600-0501.2005.01193.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.
- Individual participant dataSharing planned: Yes
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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.
Moustafa O Shehata, B.D.S. principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Orthodontic extrusion and Immediate implant placement in people with Broken 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 11 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 17 Jun 2020. 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?
Contact Moustafa O Shehata, B.D.S. (00201225897482, moustafa.hassan@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Soft tissue outcome (time frame: 12 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 NCT04436094, which also lists 19 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 17 Jun 2020.