Dental ImplantNCT06520332
Comparative Evaluation of the Clinical Efficacy of Short Implants With Standard-Length Implants - a Randomised Controlled Trial
A study testing Dental Implant Surgery - short implant group (less than or equal to 6mm) and Dental Implant Surgery - Conventional implant group (greater than or equal to 10mm) in people with Dental Implant, run by Krishnadevaraya College of Dental Sciences & Hospital at 1 site in India.
Trial summary
Periodontal disease , especially in its advanced stages , is one of the main cause for tooth loss .Tooth replacement options include dental implants , fixed partial denture , removable partial denture and complete dentures . Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implant
- What is being tested?
- Dental Implant Surgery - short implant group (less than or equal to 6mm) and Dental Implant Surgery - Conventional implant group (greater than or equal to 10mm)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIndia
- Study dates
- Aug 2024to Aug 2025
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age group - 18 years and above
- Presence of >2 mm keratinised tissue to allow flap management.
- Systemically healthy patients
- The residual vertical bone height at the implant sites ranging from 6 to 9 mm for short implant placement ; > 9 mm for standard implant placement.
- History of periodontitis
Who cannot join
- Medical conditions contraindicating surgical interventions
- Uncontrolled diabetes
- Hemorrhagic disorders
- Intravenous and oral bisphosphonate therapy.
- Irradiation in head and neck
- Pregnant and lactating women
- Subjects with known bone metabolic disorders (paget's disease , fibrous dysplasia etc.)
- Known smokers and alcoholics
Trial locations and contacts
1 site in 1 country.
India1 site
Krishnadevaraya college of dental sciences
Bangalore, Karantaka, 562157
About this study
Official title: Comparative Evaluation of the Clinical Efficacy of Short Implants With Standard-Length Implants Placed in Native/Augmented Bone of the Patients With a History of Periodontitis - A Randomised Controlled Trial
Periodontal disease , especially in its advanced stages , is one of the main cause for tooth loss .Tooth replacement options include dental implants , fixed partial denture , removable partial denture and complete dentures . Dental implants have become more common treatment for replacing missing teeth and aim to improve chewing efficiency, physical health and esthetic. Although conventional implants cannot be placed in every site due to resorption of the alveolar socket after extraction. Thus short implants can be used as an alternative . Hence, this study aims at comparing the clinical efficacy of short implants with standard length implants placed in native or augmented bone in patients with a history of periodontitis.
Read the detailed description
Implant supported prosthesis have proven as an esthetic , functional restoration with long term predictability by re-establishing appearance , comfort and mastication .
Following extraction , the bony socket undergoes significant horizontal and vertical reduction . This 3D resorption of alveolar sockets after extraction often lead to limitations for implant placement . Severe ridge atrophy complicates rehabilitation of posterior edentulous regions . This lack of adequate bone necessitates additional reconstructive surgeries such as guided bone regeneration, vertical ridge augmentation , sinus floor elevation , block grafts , distraction osteogenesis and transposition procedures of the inferior alveolar nerve to allow anatomically sound placement of dental implants . These complex surgical procedures can result in intra-operative complications like infections of graft/membranes and it's exposure and post-operative complications such as swelling , pain , nerve disturbances with an associated increased reluctance of the patient to undergo them . Also these procedures, has significantly increased treatment duration, morbidity, risk of complications and costs.
Currently , alternative procedures to avoid these additional surgeries and the associated complications encourages the use of less invasive procedures such as short implants. Short implant placements can reduce morbidity and recovery time associated with bone augmentation procedures. Thus use of shorter dental implant has shown to be a plausible solution in cases of confined space , as well as those associated with unavoidable anatomical structures , such as lingual concavities or the maxillary sinus proximation which can be prone to surgical difficulties. Short implants offer a minimally invasive approach with ease of handling , reduced surgical invasiveness and low risk of trauma to vital structures . Evidence suggests that short implants could decrease implant failure , marginal bone loss , biological complications and improve patient satisfaction. The evidence from the literature must be interpreted with caution due to the variable protocols. Clinicians require a thorough comprehension of implant dentistry to achieve predictability.Thus there is a need for well designed RCT's analysing and comparing the clinical outcomes of short implants placed in native bone with long implants placed in native or augmented bone .
Thus, the aim of the current randomised controlled clinical trial (RCT) study will be to analyse the clinical efficacy of short implants (≤6 mm) and compare it with standard length implants (≥10mm) placed in native / augmented bone in patients with history of periodontitis.
- Conditions
- Dental Implant
- Being tested
- Dental Implant Surgery - short implant group (less than or equal to 6mm), Dental Implant Surgery - Conventional implant group (greater than or equal to 10mm)
- Keywords
- Dental implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental Implant Surgery - short implant group (less than or equal to 6mm)Procedure or surgery
A mucoperiosteal flap will be raised in edentulous ridge. A short dental implant (experimental group) will be placed according to the standard protocol.
The platform of the implant will be placed 2 to 3 mm below CEJ of adjacent teeth.
The surgical wound closure will be coapted with mattress and single interrupted sutures
Dental Implant Surgery - Conventional implant group (greater than or equal to 10mm)Procedure or surgery
A mucoperiosteal flap will be raised in edentulous ridge. A standard length implant ( comparative group) ( ≥10mm) will be placed according to the standard protocol in the augmented/native bone .
The platform of the implant will be placed 2 to 3 mm below CEJ of adjacent teeth.
The surgical wound closure will be coapted with mattress and single interrupted sutures
| Study group | Role | What they receive |
|---|---|---|
| 10 Short implants will be placed in the residual vertical bone height of 5 to 8mm . | Experimental | One short dental implant will be placed whose length will be less than or equal to 6mm. Receives: Procedure: Dental Implant Surgery - short implant group (less than or equal to 6mm) |
| 10 Standard implants of length ≥ 10mm will be placed in augmented/native bone . | Active comparator | This Conventional Dental implant group will act as control. Receives: Procedure: Dental Implant Surgery - Conventional implant group (greater than or equal to 10mm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome that will be assessed is implant survival rate.
The primary objective of this randomised controlled clinical trial will be to compare the survival rate of short implants (≤ 6 mm ) and standard-length implants (≥ 10 mm) in patients with a history of periodontitis; through clinical and radiographic analysis.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study startAug 2024 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental ImplantStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06520332
- Sponsor's protocol ID
- 02_D012_00040
- Status last verified
- Jul 2024
- First submitted
- 19 Jul 2024
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data will not be shared with other researchers.
Publications
Esposito M, Barausse C, Pistilli R, Sammartino G, Grandi G, Felice P. Short implants versus bone augmentation for placing longer implants in atrophic maxillae: One-year post-loading results of a pilot randomised controlled trial. Eur J Oral Implantol. 2015 Autumn;8(3):257-68.
PubMed 26355170
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of the Clinical Efficacy of Short Implants With Standard-Length Implants Placed in Native/Augmented Bone of the Patients With a History of Periodontitis - A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06520332
- Acronym / sponsor ID
- 02_D012_00040
- Conditions
- Dental Implant
- Keywords
- Dental implant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & HospitalUniversity, hospital or other
- Study start
- Aug 2024 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 25 Jul 2024 (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.
Periodontal disease , especially in its advanced stages , is one of the main cause for tooth loss .Tooth replacement options include dental implants , fixed partial denture , removable partial denture and complete dentures . Dental implants have become more common treatment for replacing missing teeth and aim to improve chewing efficiency, physical health and esthetic. Although conventional implants cannot be placed in every site due to resorption of the alveolar socket after extraction. Thus short implants can be used as an alternative . Hence, this study aims at comparing the clinical efficacy of short implants with standard length implants placed in native or augmented bone in patients with a history of periodontitis.
Detailed description
Implant supported prosthesis have proven as an esthetic , functional restoration with long term predictability by re-establishing appearance , comfort and mastication .
Following extraction , the bony socket undergoes significant horizontal and vertical reduction . This 3D resorption of alveolar sockets after extraction often lead to limitations for implant placement . Severe ridge atrophy complicates rehabilitation of posterior edentulous regions . This lack of adequate bone necessitates additional reconstructive surgeries such as guided bone regeneration, vertical ridge augmentation , sinus floor elevation , block grafts , distraction osteogenesis and transposition procedures of the inferior alveolar nerve to allow anatomically sound placement of dental implants . These complex surgical procedures can result in intra-operative complications like infections of graft/membranes and it's exposure and post-operative complications such as swelling , pain , nerve disturbances with an associated increased reluctance of the patient to undergo them . Also these procedures, has significantly increased treatment duration, morbidity, risk of complications and costs.
Currently , alternative procedures to avoid these additional surgeries and the associated complications encourages the use of less invasive procedures such as short implants. Short implant placements can reduce morbidity and recovery time associated with bone augmentation procedures. Thus use of shorter dental implant has shown to be a plausible solution in cases of confined space , as well as those associated with unavoidable anatomical structures , such as lingual concavities or the maxillary sinus proximation which can be prone to surgical difficulties. Short implants offer a minimally invasive approach with ease of handling , reduced surgical invasiveness and low risk of trauma to vital structures . Evidence suggests that short implants could decrease implant failure , marginal bone loss , biological complications and improve patient satisfaction. The evidence from the literature must be interpreted with caution due to the variable protocols. Clinicians require a thorough comprehension of implant dentistry to achieve predictability.Thus there is a need for well designed RCT's analysing and comparing the clinical outcomes of short implants placed in native bone with long implants placed in native or augmented bone .
Thus, the aim of the current randomised controlled clinical trial (RCT) study will be to analyse the clinical efficacy of short implants (≤6 mm) and compare it with standard length implants (≥10mm) placed in native / augmented bone in patients with history of periodontitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10 Short implants will be placed in the residual vertical bone height of 5 to 8mm . | Experimental | Procedure: Dental Implant Surgery - short implant group (less than or equal to 6mm)One short dental implant will be placed whose length will be less than or equal to 6mm. |
| 10 Standard implants of length ≥ 10mm will be placed in augmented/native bone . | Active comparator | Procedure: Dental Implant Surgery - Conventional implant group (greater than or equal to 10mm)This Conventional Dental implant group will act as control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age group - 18 years and above
- Presence of >2 mm keratinised tissue to allow flap management.
- Systemically healthy patients
- The residual vertical bone height at the implant sites ranging from 6 to 9 mm for short implant placement ; > 9 mm for standard implant placement.
- History of periodontitis
Key exclusion criteria (8 listed)
- Medical conditions contraindicating surgical interventions
- Intravenous and oral bisphosphonate therapy.
- Irradiation in head and neck
- Pregnant and lactating women
- Subjects with known bone metabolic disorders (paget's disease , fibrous dysplasia etc.)
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 |
|---|---|---|
| Dental Implant Surgery - short implant group (less than or equal to 6mm)A mucoperiosteal flap will be raised in edentulous ridge. A short dental implant (experimental group) will be placed according to the standard protocol. The platform of the implant will be placed 2 to 3 mm below CEJ of adjacent teeth. The surgical wound closure will be coapted with mattress and single interrupted sutures | Procedure or surgery | 10 Short implants will be placed in the residual vertical bone height of 5 to 8mm . |
| Dental Implant Surgery - Conventional implant group (greater than or equal to 10mm)A mucoperiosteal flap will be raised in edentulous ridge. A standard length implant ( comparative group) ( ≥10mm) will be placed according to the standard protocol in the augmented/native bone . The platform of the implant will be placed 2 to 3 mm below CEJ of adjacent teeth. The surgical wound closure will be coapted with mattress and single interrupted sutures | Procedure or surgery | 10 Standard implants of length ≥ 10mm will be placed in augmented/native bone . |
Primary outcome
The primary outcome that will be assessed is implant survival rate.
Time frame: 6 months
The primary objective of this randomised controlled clinical trial will be to compare the survival rate of short implants (≤ 6 mm ) and standard-length implants (≥ 10 mm) in patients with a history of periodontitis; through clinical and radiographic analysis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Background: PubMed 26355170Esposito M, Barausse C, Pistilli R, Sammartino G, Grandi G, Felice P. Short implants versus bone augmentation for placing longer implants in atrophic maxillae: One-year post-loading results of a pilot randomised controlled trial. Eur J Oral Implantol. 2015 Autumn;8(3):257-68.
- Individual participant dataSharing planned: No. Individual Participant Data will not be shared with other researchers.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental Implant Surgery - short implant group (less than or equal to 6mm) and Dental Implant Surgery - Conventional implant group (greater than or equal to 10mm) in people with Dental Implant, run by Krishnadevaraya College of Dental Sciences & Hospital at 1 site in India.
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 8 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 25 Jul 2024. 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 India. 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?
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?
The primary outcome that will be assessed is implant survival rate. (time frame: 6 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 NCT06520332, which also lists 1 linked publication.
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 25 Jul 2024.