Bone LossNCT04195841
Influence of Z Shaped and Conventional Sulcular Incisions on Healing and Interproximal Bone Loss in Implant Surgery
A study testing Z shaped incision and H shaped incision in people with Bone Loss and Healing Surgical Wounds, run by Krishnadevaraya College of Dental Sciences & Hospital at 1 site in India.
Trial summary
The present study is a human, prospective, parallel, randomised controlled clinical trial conducted to check the interproximal bone loss of Z shaped incision over conventional sulcular H shaped incision.The trial is in accordance with the Consolidated Standards of Reporting Trials (CONSORT) criteria, 2010. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Bone Loss, Healing Surgical Wounds
- What is being tested?
- Z shaped incision and H shaped incision
- 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
- 20 Nov 2018to 1 Jan 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 Any age
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with single or multiple edentulous spaces in the maxillary and mandibular arches having Siebert's Class 1 and 2 ridge defects.
- Patients willing to participate in the study.
- Patients above 18 years of age.
- Patients exhibiting keratinized tissue width more than or equal to 2 mm.
- Systemically healthy patients.
- Patients who demonstrate full mouth plaque control and bleeding scores<25% and showing good compliance.
Who cannot join
- Patients who do not give consent.
- Untreated periodontal disease, caries.
- Insufficient oral hygiene.
- Smokers.
- Previous radiation therapy.
- Patients with known systemic diseases and conditions
- Pregnant and lactating women.
Trial locations and contacts
1 site in 1 country.
India1 site
Krishnadevaraya college of dental sciences
Bangalore, Karnataka, 562157
About this study
Official title: Influence of Z Shaped Incisions on Healing and Interproximal Bone Loss in Comparison With Conventional Sulcular Incisions (H Shaped) in Implant Surgery Under Magnification: A Randomized Clinical Trial
The present study is a human, prospective, parallel, randomised controlled clinical trial conducted to check the interproximal bone loss of Z shaped incision over conventional sulcular H shaped incision.The trial is in accordance with the Consolidated Standards of Reporting Trials (CONSORT) criteria, 2010.
Read the detailed description
Twenty healthy individuals satisfying the inclusion and exclusion criteria were recruited for the study. A detailed, thorough medical and dental history was obtained and each patient was subjected to comprehensive clinical and radiological examination. All patients were informed about the nature of the study, the surgical procedure involved, potential benefits and risks associated with the surgical procedure and written informed consent were obtained from all patients. In the test group patients Z shaped incision was done to place implants and H shaped sulcular incision was placed in control group.
The clinical and radiographic parameters were recorded at baseline,24 hours,7days, three months and six months postoperatively.
- Conditions
- Bone Loss, Healing Surgical Wounds
- Being tested
- Z shaped incision, H shaped incision
- Keywords
- implant incisions, bone loss, Z shaped incision
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Z shaped incisionProcedure or surgery
After local anaesthesia, a mucoperiosteal flap will be elevated at the edentulous ridge with two horizontal incisions placed with a no MB 69 blade, 1-2 mm away from the papilla of the teeth adjacent to the edentulous space following the mesial and distal contour of the teeth. The extend of the incisions should be up to the proximal line angles of the adjacent teeth. These two horizontal incisions are then connected by an oblique incision from the disto-buccal to mesio lingual point angles. A periosteal elevator is used to elevate a full thickness mucoperiosteal flap buccally and lingually to the level of the mucogingival junction, exposing the alveolar ridge of the implant surgical sites.
Endosseous implant placement is done followed by simple interrupted resorbable sutures
H shaped incisionProcedure or surgery
After local anaesthesia, a mucoperiosteal flap is elelevated by placing sulcular incisions placed in the proximal sides of the adjacent tooth facing the edentulous space in a bucco lingual direction extending between the proximal line angles using a MB 69 blade.
Mid crestal incision performed in the attached mucosa of the edentulous area connecting the sulcular incisions of the adjacent teeth from the distal to mesial tooth. A full thickness mucoperiosteal flap will be elevated buccally and lingually to the level of the mucogingival junction to expose the alveolar ridge of the implant surgical sites using a periosteal elevator.
Endosseous implant will be placed, followed by simple interrupted resorbable sutures.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Two horizontal incisions placed 1-2 mm away from the papilla of the teeth adjacent to the edentulous space following the mesial and distal contour of the teeth. These two horizontal incisions are then connected by an oblique incision from the disto-buccal to mesio lingual point angles. Receives: Procedure: Z shaped incision |
| Control group | Experimental | Sulcular incisions placed in the proximal sides of the adjacent tooth facing the edentulous space in a bucco lingual direction extending between the proximal line angles Mid crestal incision performed in the attached mucosa of the edentulous area connecting the sulcular incisions of the adjacent teeth from the distal to mesial tooth Receives: Procedure: H shaped incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter proximal bone level
Mesial and distal peri-implant radiographic bone level will be recorded in millimetres on the digital radiographs with grid at baseline and follow up
Measured: 6 months
Healing
Early wound healing index is assessed. values 1-5 is present. Increase in score depicts worse healing.
Measured: 7 days
Secondary outcomes (2)
Visual Analouge Score
a questionnaire will be given to the patients in which their responses for Visual Analog Score that ranges from 1-10 values and highest values indicate the worst outcome, variation in feeding habits, analgesics dosage is recorded.
Measured: 7 days
Clinical attachment level
The amount of attached gingiva was measured by subtracting the probing depth from the amount of keratinised mucosa
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start20 Nov 2018
- Primary completion31 Dec 2020
- Study completion1 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups were made one test and control. All the subjects required rehabilitation with implants.In the test group Z shaped incision was placed. in control group sulcular H shaped incision was placed.
- Masking
- None (open label)
- 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 Shobith S Mampuzha, MDS, Principal investigator, Rajiv Gandhi University of Health SciencesDr Prabhuji MLV, MDS, Principal investigator, Rajiv Gandhi University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04195841
- Sponsor's protocol ID
- 02_D012_91553
- Status last verified
- Jan 2021
- First submitted
- 10 Dec 2019
- Last updated
- 5 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Z Shaped Incisions on Healing and Interproximal Bone Loss in Comparison With Conventional Sulcular Incisions (H Shaped) in Implant Surgery Under Magnification: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04195841
- Acronym / sponsor ID
- 02_D012_91553
- Conditions
- Bone Loss, Healing Surgical Wounds
- Keywords
- implant incisions, bone loss, Z shaped incision
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & HospitalUniversity, hospital or other
- Study start
- 20 Nov 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 12 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.
The present study is a human, prospective, parallel, randomised controlled clinical trial conducted to check the interproximal bone loss of Z shaped incision over conventional sulcular H shaped incision.The trial is in accordance with the Consolidated Standards of Reporting Trials (CONSORT) criteria, 2010.
Detailed description
Twenty healthy individuals satisfying the inclusion and exclusion criteria were recruited for the study. A detailed, thorough medical and dental history was obtained and each patient was subjected to comprehensive clinical and radiological examination. All patients were informed about the nature of the study, the surgical procedure involved, potential benefits and risks associated with the surgical procedure and written informed consent were obtained from all patients. In the test group patients Z shaped incision was done to place implants and H shaped sulcular incision was placed in control group.
The clinical and radiographic parameters were recorded at baseline,24 hours,7days, three months and six months postoperatively.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups were made one test and control. All the subjects required rehabilitation with implants.In the test group Z shaped incision was placed. in control group sulcular H shaped incision was placed.
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Procedure: Z shaped incisionTwo horizontal incisions placed 1-2 mm away from the papilla of the teeth adjacent to the edentulous space following the mesial and distal contour of the teeth. These two horizontal incisions are then connected by an oblique incision from the disto-buccal to mesio lingual point angles. |
| Control group | Experimental | Procedure: H shaped incisionSulcular incisions placed in the proximal sides of the adjacent tooth facing the edentulous space in a bucco lingual direction extending between the proximal line angles Mid crestal incision performed in the attached mucosa of the edentulous area connecting the sulcular incisions of the adjacent teeth from the distal to mesial tooth |
Who may qualify
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with single or multiple edentulous spaces in the maxillary and mandibular arches having Siebert's Class 1 and 2 ridge defects.
- Patients willing to participate in the study.
- Patients above 18 years of age.
- Patients exhibiting keratinized tissue width more than or equal to 2 mm.
- Systemically healthy patients.
Key exclusion criteria (7 listed)
- Patients who do not give consent.
- Untreated periodontal disease, caries.
- Insufficient oral hygiene.
- Smokers.
- Previous radiation therapy.
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 |
|---|---|---|
| Z shaped incisionAfter local anaesthesia, a mucoperiosteal flap will be elevated at the edentulous ridge with two horizontal incisions placed with a no MB 69 blade, 1-2 mm away from the papilla of the teeth adjacent to the edentulous space following the mesial and distal contour of the teeth. The extend of the incisions should be up to the proximal line angles of the adjacent teeth. These two horizontal incisions are then connected by an oblique incision from the disto-buccal to mesio lingual point angles. A periosteal elevator is used to elevate a full thickness mucoperiosteal flap buccally and lingually to the level of the mucogingival junction, exposing the alveolar ridge of the implant surgical sites. Endosseous implant placement is done followed by simple interrupted resorbable sutures | Procedure or surgery | Test group |
| H shaped incisionAfter local anaesthesia, a mucoperiosteal flap is elelevated by placing sulcular incisions placed in the proximal sides of the adjacent tooth facing the edentulous space in a bucco lingual direction extending between the proximal line angles using a MB 69 blade. Mid crestal incision performed in the attached mucosa of the edentulous area connecting the sulcular incisions of the adjacent teeth from the distal to mesial tooth. A full thickness mucoperiosteal flap will be elevated buccally and lingually to the level of the mucogingival junction to expose the alveolar ridge of the implant surgical sites using a periosteal elevator. Endosseous implant will be placed, followed by simple interrupted resorbable sutures. | Procedure or surgery | Control group |
Primary outcome
Inter proximal bone level
Time frame: 6 months
Mesial and distal peri-implant radiographic bone level will be recorded in millimetres on the digital radiographs with grid at baseline and follow up
Healing
Time frame: 7 days
Early wound healing index is assessed. values 1-5 is present. Increase in score depicts worse healing.
2 secondary outcomes
Visual Analouge Score
Time frame: 7 days
Clinical attachment level
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
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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 Shobith S Mampuzha, MDS principal investigator
Rajiv Gandhi University of Health Sciences
Dr Prabhuji MLV, MDS principal investigator
Rajiv Gandhi University of Health 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 Z shaped incision and H shaped incision in people with Bone Loss and Healing Surgical Wounds, 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 6 inclusion and 7 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 5 Jan 2021. 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?
Inter proximal bone level (time frame: 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 5 Jan 2021.