Dental ImplantsNCT04189328
Peri-implant Papillary Height Comparison in Microsurgically and Macrosurgically Placed Dental Implants
A study testing dental implant placement using magnifying loupes and microsurgical instruments and macrosurgical dental implant placement in people with Dental Implants, run by Krishnadevaraya College of Dental Sciences & Hospital at 1 site in India.
Trial summary
This study compares the peri-implant soft tissue and crestal bone loss around single implants when placed macrosurgically and microsurgically. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implants
- What is being tested?
- dental implant placement using magnifying loupes and microsurgical instruments and macrosurgical dental implant placement
- 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
- 10 Dec 2017to 30 Sep 2019
- 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
- Patients desiring implant placement for replacement of missing tooth and willing to participate in the study
- Non smokers
- Patients who do not report any relevant medically comprimising conditions or had not received any radiation therapy in head and neck region for cancer therapy.
- Subjects with satisfactory residual ridges who demonstrated adequate bucco-lingual and mesio-distal space for implant placement, that facilitates primary stability.
- Patients who demonstrate Plaque Index <10% and good compliance.
- Full mouth bleeding scores ≤25% before the implant placement.
- Sites with sufficient band of keratinised mucosa.
Who cannot join
- • Pregnant and lactating females
- Patients on anticancer therapy and immunosuppressant drugs.
- Implants to be placed in sites with previous periodontal disease
- Bleeding disorder or on anticoagulant therapy
- Systemic diseases that would negatively influence wound healing
Trial locations and contacts
1 site in 1 country.
India1 site
Krishnadevaraya college of dental sciences and hospital
Bangalore, Karnataka, 562157
About this study
Official title: Clinical and Radiological Comparison of Peri Implant Soft Tissue Parameters and Crestal Bone Loss Around Microsurgically and Macrosurgically Placed Implants: A Randomised Controlled Clinical Trail
This study compares the peri-implant soft tissue and crestal bone loss around single implants when placed macrosurgically and microsurgically.
Read the detailed description
Black triangles in dentition especially in the anterior teeth would pose an esthetic concern. Interdental papilla height is crucial for eliminating this black triangle.
32 participants, 16 in two groups were assigned randomly. Microsurgical approach using microsurgical instruments and magnifying loupes were used for one group participants and similar procedure without magnifying loupes and microsurgical instruments was done in the other group.
comparsion of the microsurgical outcome is done by measuring peri implant papilla gain and radiographic crestal bone loss will be done between the groups.
- Conditions
- Dental Implants
- Being tested
- dental implant placement using magnifying loupes and microsurgical instruments, macrosurgical dental implant placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dental implant placement using magnifying loupes and microsurgical instrumentsProcedure or surgery
microsurgical dental implant placement employin splt finger technique by Misch
macrosurgical dental implant placementProcedure or surgery
macrosurgical placement of single dental implants
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | conventional macrosurgical implant placement Receives: Procedure: macrosurgical dental implant placement |
| test group | Experimental | microsurgical implant placement Receives: Procedure: dental implant placement using magnifying loupes and microsurgical instruments |
What is being measured
The primary outcome is the main question the study is designed to answer.
peri-implant papilla height
mesial and distal peri implant papilla height is measured in millimeter
Measured: 1 year
marginal gingiva
buccal marginal gingival height is measured
Measured: 1 year
jemt papilla index
papillary height gained around implant is scored using jemt papilla index 0 = no papilla and no indication of a curvature of the soft tissue adjacent to the implant crown are present;
- = less than one-half of the papilla height is present, and a convex curvature of the soft tissue adjacent to the implant crown and adjacent tooth can be observed;
- = at least one-half of the papilla height is present but not to the contact point between the teeth, the papilla is not completely harmonious with the adjacent papillae between the permanent teeth, and soft tissue is harmonious with adjacent teeth;
- = the papilla fills the entire proximal space and is harmonious with the adjacent papillae, and soft-tissue contour is optimal;
- = the papillae are hyperplastic and cover too much of the implant or the adjacent tooth, and the soft-tissue contour is irregular
Measured: 1 year
crestal bone loss
radiographic crestal bone level around the implants measured from 1st thread of the implant to the coronal or apical most bone level in millimeters.
Measured: 1 year
pink esthetic score
scoring assigned to 7 soft tissue criteria by an examiner as 0,1,2,3 and the average of the total score is considered the final score. a maximum score of 14 can be alloted
Measured: 1 year
Secondary outcomes (5)
surgical time taken
the time taken right from the incision to the implant placement is watched and recorded.
Measured: 1 day
visual analogue scale score
aesthetic score by the outcome investigator using VAS score sheet of 10 points. 1 being most painful and 10 being painless
Measured: 1 year
probing depth
peri implant probing depth at each follow up was recorded
Measured: 1 year
plaque index
plaque scores were recorded at each follow up 0.-0.9 good 1.0-1.9-fair 2-3-poor
Measured: 1 year
gingival index
gingival index scores were recorded at each followup 0.1-1-mild gingivitis 1.1-2- moderate gingivitis 2.1-3 severe gingivitis
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2019
- Study start10 Dec 2017
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantsStudies 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
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr.Joann pauline George, MDS, Principal investigator, Krishnadevaraya college of dental sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04189328
- Sponsor's protocol ID
- 02_D012_82168
- Status last verified
- Dec 2019
- First submitted
- 4 Dec 2019
- Last updated
- 10 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiological Comparison of Peri Implant Soft Tissue Parameters and Crestal Bone Loss Around Microsurgically and Macrosurgically Placed Implants: A Randomised Controlled Clinical Trail
- ClinicalTrials.gov ID
- NCT04189328
- Acronym / sponsor ID
- 02_D012_82168
- Conditions
- Dental Implants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & HospitalUniversity, hospital or other
- Study start
- 10 Dec 2017 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 6 Dec 2019 (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.
This study compares the peri-implant soft tissue and crestal bone loss around single implants when placed macrosurgically and microsurgically.
Detailed description
Black triangles in dentition especially in the anterior teeth would pose an esthetic concern. Interdental papilla height is crucial for eliminating this black triangle.
32 participants, 16 in two groups were assigned randomly. Microsurgical approach using microsurgical instruments and magnifying loupes were used for one group participants and similar procedure without magnifying loupes and microsurgical instruments was done in the other group.
comparsion of the microsurgical outcome is done by measuring peri implant papilla gain and radiographic crestal bone loss will be done between the groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Procedure: macrosurgical dental implant placementconventional macrosurgical implant placement |
| test group | Experimental | Procedure: dental implant placement using magnifying loupes and microsurgical instrumentsmicrosurgical implant placement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients desiring implant placement for replacement of missing tooth and willing to participate in the study
Key exclusion criteria (5 listed)
- • Pregnant and lactating females
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 placement using magnifying loupes and microsurgical instrumentsmicrosurgical dental implant placement employin splt finger technique by Misch | Procedure or surgery | test group |
| macrosurgical dental implant placementmacrosurgical placement of single dental implants | Procedure or surgery | control group |
Primary outcome
peri-implant papilla height
Time frame: 1 year
mesial and distal peri implant papilla height is measured in millimeter
marginal gingiva
Time frame: 1 year
buccal marginal gingival height is measured
jemt papilla index
Time frame: 1 year
papillary height gained around implant is scored using jemt papilla index 0 = no papilla and no indication of a curvature of the soft tissue adjacent to the implant crown are present; 1. = less than one-half of the papilla height is present, and a convex curvature of the soft tissue adjacent to the implant crown and adjacent tooth can be observed; 2. = at least one-half of the papilla height is present but not to the contact point between the teeth, the papilla is not completely harmonious with the adjacent papillae between the permanent teeth, and soft tissue is harmonious with adjacent teeth; 3. = the papilla fills the entire proximal space and is harmonious with the adjacent papillae, and soft-tissue contour is optimal; 4. = the papillae are hyperplastic and cover too much of the implant or the adjacent tooth, and the soft-tissue contour is irregular
crestal bone loss
Time frame: 1 year
radiographic crestal bone level around the implants measured from 1st thread of the implant to the coronal or apical most bone level in millimeters.
pink esthetic score
Time frame: 1 year
scoring assigned to 7 soft tissue criteria by an examiner as 0,1,2,3 and the average of the total score is considered the final score. a maximum score of 14 can be alloted
5 secondary outcomes
surgical time taken
Time frame: 1 day
visual analogue scale score
Time frame: 1 year
probing depth
Time frame: 1 year
plaque index
Time frame: 1 year
gingival index
Time frame: 1 year
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 10 Dec 2019.
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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.
Dr.Joann pauline George, MDS principal investigator
Krishnadevaraya college of dental sciences
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 placement using magnifying loupes and microsurgical instruments and macrosurgical dental implant placement in people with Dental Implants, 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 7 inclusion and 5 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 10 Dec 2019. 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?
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?
peri-implant papilla height (time frame: 1 year). 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?
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 10 Dec 2019.