Alveolar Bone LossNCT04375839
Zirconia Vs Titanium Implants in Deficient Ridges
A study testing Zirconia implant and Titanium implant in people with Alveolar Bone Loss and Periodontitis, run by SVS Institute of Dental Sciences at 1 site in India.
Trial summary
The aim of this study is to evaluate clinically and radiographically soft tissue around single-implant crowns and peri-implant bone resorption respectively by using zirconia implants or titanium implants in horizontally deficient partially edentulous ridges. Read more about this study
- Who is it for?
- Ages 25 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Loss, Periodontitis
- What is being tested?
- Zirconia implant and Titanium implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIndia
- Study dates
- 6 Mar 2020to Nov 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 25 to 44 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- Medically compromised patients
- -. Subjects who underwent radiotherapy or chemotherapy and with
- Habit of smoking, tobacco and alcohol abuse
- Subjects with active periodontal disease to residual dentition and lack of oral hygiene will be excluded from this study.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
SVS Institute of Dental Sciences
Hyderabad, Telangana, 509002
R V Chandra, MDS;DNB;PhD, 9908183071, viswachandra@hotmail.com
About this study
Official title: Zirconia Vs Titanium Implants in Horizontally Deficient Ridges - A Clinical and Radiographic Outcome-Based Study
The aim of this study is to evaluate clinically and radiographically soft tissue around single-implant crowns and peri-implant bone resorption respectively by using zirconia implants or titanium implants in horizontally deficient partially edentulous ridges.
Read the detailed description
Experimental: Main treatment group Zirconia implants will be placed in a prosthetically guided position in horizontally deficient ridges in main treatment group.
Active Comparator: Control group Titanium implants will be placed in a prosthetically guided position in horizontally deficient ridges in control group.
- Conditions
- Alveolar Bone Loss, Periodontitis
- Being tested
- Zirconia implant, Titanium implant
- Medical subject headings
- Alveolar Bone Loss, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zirconia implantDevice
Also called Experimental group
Following standard surgical protocol, Zirconia implant will be placed in horizontally deficient ridge.
Titanium implantDevice
Also called Control group
Following standard surgical protocol, Titanium implant will be placed in horizontally deficient ridge.
| Study group | Role | What they receive |
|---|---|---|
| Main treatment group | Experimental | Zirconia implants will be placed in a prosthetically guided position in horizontally deficient ridges in main treatment group. Receives: Device: Zirconia implant |
| Control group | Active comparator | Titanium implants will be placed in a prosthetically guided position in horizontally deficient ridges in control group. Receives: Device: Titanium implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the soft tissue around single implant crowns
Pink Esthetic Score (0-2; increasing scores means improvement in clinical outcomes) is used to evaluate the soft tissue around single implant crowns that might change over time at 3 months and 6 months.
Measured: Baseline to 6 months
Peri-implant bone resorption
measured in terms of vertical bone levels present mesial and distal to implant which will be measured by comparing CBCT
Measured: Baseline to 6 months
Secondary outcomes (1)
Implant survival rate
Implant survival rate before and after prosthetic loading based on Criteria: A) Persistent pain or dysesthesia B) Peri-implant infection with suppuration C) Absence of mobility D) Absence of continuous peri-implant radiolucency, but with peri-implant bone resorption assessed using dichotomous scale.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start6 Mar 2020
- Primary completionSep 2020 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone LossStudies 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, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SVS Institute of Dental Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr R Viswa Chandra, SVS Institute of Dental Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04375839
- Sponsor's protocol ID
- SVSIDS/PERIO/1/2019
- Status last verified
- May 2020
- First submitted
- 29 Apr 2020
- Last updated
- 7 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zirconia Vs Titanium Implants in Horizontally Deficient Ridges - A Clinical and Radiographic Outcome-Based Study
- ClinicalTrials.gov ID
- NCT04375839
- Acronym / sponsor ID
- SVSIDS/PERIO/1/2019
- Conditions
- Alveolar Bone Loss, Periodontitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- SVS Institute of Dental SciencesUniversity, hospital or other
- Study start
- 6 Mar 2020 (actual)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 5 May 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.
The aim of this study is to evaluate clinically and radiographically soft tissue around single-implant crowns and peri-implant bone resorption respectively by using zirconia implants or titanium implants in horizontally deficient partially edentulous ridges.
Detailed description
Experimental: Main treatment group Zirconia implants will be placed in a prosthetically guided position in horizontally deficient ridges in main treatment group.
Active Comparator: Control group Titanium implants will be placed in a prosthetically guided position in horizontally deficient ridges in control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Main treatment group | Experimental | Device: Zirconia implantZirconia implants will be placed in a prosthetically guided position in horizontally deficient ridges in main treatment group. |
| Control group | Active comparator | Device: Titanium implantTitanium implants will be placed in a prosthetically guided position in horizontally deficient ridges in control group. |
Who may qualify
- Ages
- 25 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- Medically compromised patients
- -. Subjects who underwent radiotherapy or chemotherapy and with
- Habit of smoking, tobacco and alcohol abuse
- Subjects with active periodontal disease to residual dentition and lack of oral hygiene will be excluded from this study.
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 |
|---|---|---|
| Zirconia implantAlso: Experimental groupFollowing standard surgical protocol, Zirconia implant will be placed in horizontally deficient ridge. | Device | Main treatment group |
| Titanium implantAlso: Control groupFollowing standard surgical protocol, Titanium implant will be placed in horizontally deficient ridge. | Device | Control group |
Primary outcome
Evaluation of the soft tissue around single implant crowns
Time frame: Baseline to 6 months
Pink Esthetic Score (0-2; increasing scores means improvement in clinical outcomes) is used to evaluate the soft tissue around single implant crowns that might change over time at 3 months and 6 months.
Peri-implant bone resorption
Time frame: Baseline to 6 months
measured in terms of vertical bone levels present mesial and distal to implant which will be measured by comparing CBCT
1 secondary outcome
Implant survival rate
Time frame: Baseline to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2020.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zirconia implant and Titanium implant in people with Alveolar Bone Loss and Periodontitis, run by SVS Institute of Dental Sciences 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 0 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: status not confirmed, as of the sponsor's last update on 7 May 2020. 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?
Contact R V Chandra, MDS;DNB;PhD (9908183071, viswachandra@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the soft tissue around single implant crowns (time frame: Baseline to 6 months). 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?
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 7 May 2020.