Tooth LossNCT02996370
Effect of I-Shape Incısıon Technique on Inter-Implant Papilla: A Prospective Randomized Clinical Trial
A study testing papilla fill index, crestal bone loss and probing depth in people with Tooth Loss and Bone Loss, run by Ege University.
Trial summary
Regenerating a predictable inter-implant papilla is the most complex and challenging aspect of implant dentistry. The aim of the study was to compare the efficacy of I shaped incision technique and conventional midcrestal incision technique for interimplant papilla reconstruction in a 6 month clinical trial. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth Loss, Bone Loss
- What is being tested?
- papilla fill index, crestal bone loss and probing depth
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Oct 2010to Sep 2011
- 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
- No sistemic condition, and age > 18 years,
- healthy soft tissue (bleeding on probing (BOP) ≤ 20%, Plaque Index ≤ 15%,
- in a need of at least two collateral implants in the maxilla from second premolar to second premolar
- sufficient keratinized tissue
- no bone augmentation procedures before implant placement
- use of tobacco 10N ≥ cigarettes daily
- sufficient distance between opposite occluding dentition at the proposed implant sites
Who cannot join
- history of aggressive periodontitis,
- systemic diseases such as diabetes
- pregnant or lactating women
- radiation therapy in the head and neck area wihtin the previous 12 months,
- heavy smokers
- bruxism.
About this study
Regenerating a predictable inter-implant papilla is the most complex and challenging aspect of implant dentistry. The aim of the study was to compare the efficacy of I shaped incision technique and conventional midcrestal incision technique for interimplant papilla reconstruction in a 6 month clinical trial.
Read the detailed description
A total of 40 implants were placed in 12 patients. Groups were determined at second stage surgery, I shape technique used in test group and mid-crestal technique used in control group. The clinical parameters, including modified plaque index, modified sulcus bleeding index, probing depth, keratinized tissue level were recorded baseline, 3 and 6 month. The vertical distance between the crests top-contact point was evaluated with digital periapical radiographs at baseline 3 and 6 month. Also the clinical photographs were taken baseline, 3 and 6 month. Two T shaped full-round hexagonal straight filaments, each 5 mm, were used in the taking of standardized images. With these images the ratio of the papilla area in proportion to the embrasure area and the papilla classification was measured. Non-parametric test were used for statistically analysis.
- Conditions
- Tooth Loss, Bone Loss
- Being tested
- papilla fill index, crestal bone loss, probing depth, Modified sulcus bleeding index, Modified plaque index
- Keywords
- esthetic, inter-implant papilla, soft tissue tickness, crestal bone loss, second stage surgery
- Medical subject headings
- Tooth Loss, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
papilla fill indexOther
The clinical photographs were taken baseline, 3 and 6 month. Two T shaped full-round hexagonal straight filaments, each 5 mm, were used in the taking of standardized images.
crestal bone lossOther
Crestal bone loss was measured on digital radiographs at baseline, 3 and 6 month with a Java program me (Image-J 3.0 NIH, Bethesda, USA)
probing depthOther
The change of probing depth between baseline, 3 and 6month. Probing depth was measured with a plastic periodontal probe (mm)
Modified sulcus bleeding indexOther
Modified bleeding index was measured baseline, 3 and 6 month. Presence of bleeding on probing were performed at four sites of implants.
Modified plaque indexOther
Modified plaque index was measured baseline, 3 and 6 month. Presence of plaque index was performed at four sites of implants.
| Study group | Role | What they receive |
|---|---|---|
| Test group- ı shape incision | Active comparator | Second stage surgery was made I shape incision technique . Receives: Other: papilla fill index; Other: crestal bone loss; Other: probing depth; Other: Modified sulcus bleeding index; Other: Modified plaque index |
| Control group- midcrestal incision | Active comparator | In the control group second stage surgery was made using the conventional method, midcrestal technique. Receives: Other: papilla fill index; Other: crestal bone loss; Other: probing depth; Other: Modified sulcus bleeding index; Other: Modified plaque index |
What is being measured
The primary outcome is the main question the study is designed to answer.
papilla fill index
Baseline will be 1 week after cementation of the crowns.
Measured: baseline
papilla fill index
Papilla fill index will be recorded 3rd month after baseline
Measured: 3 month
papilla fill index
Papilla fill index will be recorded 6th month after baseline
Measured: 6 month
crestal bone loss
Crestal bone loss was measured on radiographs between baseline-3rd month.
Measured: Change from baseline crestal bone level up to 3 months
crestal bone loss
Crestal bone loss was measured on radiographs between baseline-6th month.
Measured: Change from baseline crestal bone level up to 6 months
vertical distance
Inter-implant vertical distance between the crests top-contact point was also evaluated with digital periapical radiographs.
Measured: baseline, 3 and 6 month
Secondary outcomes (12)
Probing depth
The level of probing depth at baseline. Probing depth was measured with a plastic periodontal probe.
Measured: baseline
Probing depth
The level of probing depth at 3 month. Probing depth was measured with a plastic periodontal probe.
Measured: 3 month
Probing depth
The level of probing depth at 6 month. Probing depth was measured with a plastic periodontal probe.
Measured: 6 month
Modified sulcus bleeding index
Modified sulcus bleeding index was recorded at four sites of implants after 10 sec. of probing.
Measured: Modified sulcus bleeding index was recorded at baseline
Modified sulcus bleeding index
Modified sulcus bleeding index was recorded at four sites of implants after 10 sec. of probing.
Measured: Modified sulcus bleeding index was recorded at 3 month
Modified sulcus bleeding index
Modified sulcus bleeding index was recorded at four sites of implants after 10 sec. of probing.
Measured: Modified sulcus bleeding index was recorded at 6 month
Modified plaque index
The dichotomous presence of supra gingival plaque was recorded at four sites of implants
Measured: Modified plaque index was recorded at baseline
Modified plaque index
The dichotomous presence of supra gingival plaque was recorded at four sites of implants
Measured: Modified plaque index was recorded at 3 month
Modified plaque index
The dichotomous presence of supra gingival plaque was recorded at four sites of implants
Measured: Modified plaque index was recorded at 6 month
Keratinized tissue level
Keratinized tissue level measured with a plastic periodontal probe
Measured: Keratinized tissue level was recorded at baseline
Keratinized tissue level
Keratinized tissue level measured with a plastic periodontal probe
Measured: Keratinized tissue level was recorded at 3 month
Keratinized tissue level
Keratinized tissue level measured with a plastic periodontal probe
Measured: Keratinized tissue level was recorded at 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2016 (estimated)
- Study startOct 2010
- Primary completionJul 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth LossStudies of the same condition, open and under way.
- More trials run by Ege 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özge PEHLİVANOĞLU, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02996370
- Sponsor's protocol ID
- EGE-OP 2013
- Status last verified
- Dec 2016
- First submitted
- 8 Dec 2016
- Last updated
- 19 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of I-Shape Incısıon Technique on Inter-Implant Papilla: A Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02996370
- Acronym / sponsor ID
- EGE-OP 2013
- Conditions
- Tooth Loss, Bone Loss
- Keywords
- esthetic, inter-implant papilla, soft tissue tickness, crestal bone loss, second stage surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 19 Dec 2016 (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.
Regenerating a predictable inter-implant papilla is the most complex and challenging aspect of implant dentistry. The aim of the study was to compare the efficacy of I shaped incision technique and conventional midcrestal incision technique for interimplant papilla reconstruction in a 6 month clinical trial.
Detailed description
A total of 40 implants were placed in 12 patients. Groups were determined at second stage surgery, I shape technique used in test group and mid-crestal technique used in control group. The clinical parameters, including modified plaque index, modified sulcus bleeding index, probing depth, keratinized tissue level were recorded baseline, 3 and 6 month. The vertical distance between the crests top-contact point was evaluated with digital periapical radiographs at baseline 3 and 6 month. Also the clinical photographs were taken baseline, 3 and 6 month. Two T shaped full-round hexagonal straight filaments, each 5 mm, were used in the taking of standardized images. With these images the ratio of the papilla area in proportion to the embrasure area and the papilla classification was measured. Non-parametric test were used for statistically analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group- ı shape incision | Active comparator | Other: papilla fill index, Other: crestal bone loss, Other: probing depth, Other: Modified sulcus bleeding index, Other: Modified plaque indexSecond stage surgery was made I shape incision technique . |
| Control group- midcrestal incision | Active comparator | Other: papilla fill index, Other: crestal bone loss, Other: probing depth, Other: Modified sulcus bleeding index, Other: Modified plaque indexIn the control group second stage surgery was made using the conventional method, midcrestal technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- No sistemic condition, and age > 18 years,
- healthy soft tissue (bleeding on probing (BOP) ≤ 20%, Plaque Index ≤ 15%,
- in a need of at least two collateral implants in the maxilla from second premolar to second premolar
- sufficient keratinized tissue
- no bone augmentation procedures before implant placement
Key exclusion criteria (6 listed)
- history of aggressive periodontitis,
- systemic diseases such as diabetes
- pregnant or lactating women
- radiation therapy in the head and neck area wihtin the previous 12 months,
- heavy smokers
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 |
|---|---|---|
| papilla fill indexThe clinical photographs were taken baseline, 3 and 6 month. Two T shaped full-round hexagonal straight filaments, each 5 mm, were used in the taking of standardized images. | Other | Control group- midcrestal incision, Test group- ı shape incision |
| crestal bone lossCrestal bone loss was measured on digital radiographs at baseline, 3 and 6 month with a Java program me (Image-J 3.0 NIH, Bethesda, USA) | Other | Control group- midcrestal incision, Test group- ı shape incision |
| probing depthThe change of probing depth between baseline, 3 and 6month. Probing depth was measured with a plastic periodontal probe (mm) | Other | Control group- midcrestal incision, Test group- ı shape incision |
| Modified sulcus bleeding indexModified bleeding index was measured baseline, 3 and 6 month. Presence of bleeding on probing were performed at four sites of implants. | Other | Control group- midcrestal incision, Test group- ı shape incision |
| Modified plaque indexModified plaque index was measured baseline, 3 and 6 month. Presence of plaque index was performed at four sites of implants. | Other | Control group- midcrestal incision, Test group- ı shape incision |
Primary outcome
papilla fill index
Time frame: baseline
Baseline will be 1 week after cementation of the crowns.
papilla fill index
Time frame: 3 month
Papilla fill index will be recorded 3rd month after baseline
papilla fill index
Time frame: 6 month
Papilla fill index will be recorded 6th month after baseline
crestal bone loss
Time frame: Change from baseline crestal bone level up to 3 months
Crestal bone loss was measured on radiographs between baseline-3rd month.
crestal bone loss
Time frame: Change from baseline crestal bone level up to 6 months
Crestal bone loss was measured on radiographs between baseline-6th month.
vertical distance
Time frame: baseline, 3 and 6 month
Inter-implant vertical distance between the crests top-contact point was also evaluated with digital periapical radiographs.
12 secondary outcomes
Probing depth
Time frame: baseline
Probing depth
Time frame: 3 month
Probing depth
Time frame: 6 month
Modified sulcus bleeding index
Time frame: Modified sulcus bleeding index was recorded at baseline
Modified sulcus bleeding index
Time frame: Modified sulcus bleeding index was recorded at 3 month
Modified sulcus bleeding index
Time frame: Modified sulcus bleeding index was recorded at 6 month
Modified plaque index
Time frame: Modified plaque index was recorded at baseline
Modified plaque index
Time frame: Modified plaque index was recorded at 3 month
Modified plaque index
Time frame: Modified plaque index was recorded at 6 month
Keratinized tissue level
Time frame: Keratinized tissue level was recorded at baseline
Keratinized tissue level
Time frame: Keratinized tissue level was recorded at 3 month
Keratinized tissue level
Time frame: Keratinized tissue level was recorded at 6 month
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 19 Dec 2016.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing papilla fill index, crestal bone loss and probing depth in people with Tooth Loss and Bone Loss, run by Ege 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 7 inclusion and 6 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 19 Dec 2016. 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?
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?
papilla fill index (time frame: baseline). The study lists 6 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 19 Dec 2016.