Bone LossVertikalNCT06322901
The Effect Of Vertical Releasing Incision On Implant Procedures
A study testing Flap in people with Bone Loss and Flap Design, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
This study evaluated the clinical and biochemical aspects of flap design in dental implant applications regarding implantation success and patient comfort. In this split-mouth randomized controlled clinical trial, a vertical releasing incision was made at the distal end of the crestal incision on the test side, and… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Loss, Flap Design
- What is being tested?
- Flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Aug 2018to 2 Oct 2020
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with bilateral tooth deficiency in the lower jaw posterior region who received 2 dental implants on the right and left sides were recruited from the Erciyes University Faculty of Dentistry Department of Periodontology between December 2018 and January 2020
Who cannot join
- Patients were excluded if they had any systemic disease, demonstrated bone structure unsuitable for a 3.7 × 10 mm dental implant, were pregnant, had previously received radiotherapy or chemotherapy, had a tooth extracted from the implant area within 6 months, had active periodontal disease, required antibiotic prophylaxis, had inadequate keratinized gingiva, or demonstrated a tissue phenotype >2 mm.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erciyes University Faculty of Dentistry
Melikgazi, Kayseri, 38039
About this study
Official title: Examination Of The Effect Of Vertical Releasing Incision On Implant Procedures: A Randomized Controlled Split-Mouth Study
This study evaluated the clinical and biochemical aspects of flap design in dental implant applications regarding implantation success and patient comfort. In this split-mouth randomized controlled clinical trial, a vertical releasing incision was made at the distal end of the crestal incision on the test side, and the control side received a crestal incision alone. Sixty-eight implants were placed in 17 patients. Peri-implant groove fluid was collected on postsurgical days 3, 7, 30, and 90; OPG and RANKL levels were assessed to determine bone formation and resorption around the implants. Cortisol levels were assessed in peri-implant groove fluid at postsurgical days 3, 7, and 14. Visual analog scale (VAS), and swelling measurements were taken postoperatively. Panoramic and periapical X-rays were obtained immediately post-surgery and at 3 months. No significant marginal bone loss difference was observed between the test and control sides at 3 months. The RANKL/OPG ratio, cortisol levels, VAS scores, and swelling scores were higher in the test vs. control sides. Overall, while the use of a vertical incision has advantages, such as increasing the visual field of the surgeon and improving the ease of the operation, this approach should be used only when necessary, given the disadvantages of increased bone resorption mediators in the peri-implant tissue and reduced postoperative patient comfort.
Read the detailed description
Dental implantation is the most widely used method for treating edentulous patients. The most important factors affecting dental implant success are the patient's systemic condition, the material used, the physical properties of the implant, and the surgical protocol. Flap design is the first and most important stage of dental implant surgery. The most commonly used surgical technique for implant placement elevates the full-thickness mucoperiosteal flap. Flap design is critical in this procedure to reduce patient pain, limit stress-related cortisol level increases, and prevent peri-implant bone loss. An ideal flap reveals the entire surgical area, allowing the surgeon to work comfortably and place the implant in the desired position; thus, a vertical incision can be added to the flap. However, recent studies have demonstrated that a minimally invasive flap design reduces postoperative pain, bleeding, crestal bone loss, and surgical time. Several other studies concluded that flap designs with or without a vertical incision are equally successful.
Marginal bone resorption also influences long-term implantation success. Marginal bone resorption is aggravated by flap design and increases in cortisol secretion due to patient pain. High cortisol and β-endorphin concentrations can significantly increase MMP-1, MMP-2, MMP-7, MMP-11, and TIMP-1 levels in human gingival fibroblasts, explaining the increase in periodontal and peri-implant destruction associated with physiological stress. Several studies have offered acceptable explanations for the relationship between oral health (especially periodontal health) and psychological stres. The pathophysiological effects of periodontal disease are directly related to host resistance and affect the immune system. A positive relationship between salivary cortisol levels and stress levels has also been observed in individuals with severe periodontal disease. Marginal bone resorption around implants can be measured biochemically by examining substances in the peri-implant crevicular fluid, such as the markers osteoprotegerin (OPG) and receptor-activator NFkB ligand (RANKL). RANKL is a membrane-bound factor expressed on the outer surfaces of osteoblast cells and plays a central role in osteoclast cell formation and development. OPG binds to RANKL and prevents it from interacting with its receptor, NFkB, on osteoclasts and preosteoclasts, preventing bone loss. The OPG/RANKL ratio in the peri-implant groove fluid can indicate marginal bone resorption around dental implants; healthy implants demonstrate greater OPG/RANKL ratios than those with active marginal bone resorption. Thus, the effects of flap design on marginal bone loss (MBL) can be compared via the OPG/RANKL ratio.
Pain also causes systemic changes. The levels of cortisol, dehydroepiandrosterone, testosterone, and thyroid-stimulating hormone in bodily fluids can indicate a patient's pain level. Cortisol is controlled by adrenocorticotropic hormone (ACTH) released from the anterior pituitary gland. Most physical or neurological stressors strongly increase ACTH secretion, and dental stress increases bodily fluid hormone levels.
A literature review revealed insufficient studies examining the effects of a vertical incision on the peri-implant bone level. Existing studies only include clinical or radiological evaluations. This study aimed to evaluate the clinical effects of flap design and incision on dental implants by administering a visual analog scale (VAS) questionnaire, measuring swelling, recording the flap surgery duration, assessing the OPG/RANKL ratio and cortisol levels in the peri-implant groove fluid, and taking periapical X-ray images. Our study is unique and comprehensive since it addresses the clinical, biochemical, and radiological effects of a vertical incision on implants. In addition, although various studies have included cortisol measurements in the gingival crevicular fluid, few have measured cortisol in peri-implant groove fluid. Our findings suggest that flap designs with a vertical incision cause early marginal bone loss and additional stress on dental implant recipients.
- Conditions
- Bone Loss, Flap Design
- Being tested
- Flap
- Keywords
- flap design, vertical incision, OPG-RANKL, cortisol
- 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.
FlapProcedure or surgery
Different flap designs for implant placement
| Study group | Role | What they receive |
|---|---|---|
| test side | Experimental | A mid-crestal incision was made on the test side with a no. 12 scalpel and a sulcular incision was made around the first natural tooth and a 5-mm vertical incision was made disto-obliquely to the distal crestal incision Receives: Procedure: Flap |
| control side | Active comparator | Only a mid-crestal incision was made on the control side with a no. 12 scalpel and a sulcular incision was made around the first natural tooth Receives: Procedure: Flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone loss
The degree of marginal bone loss (MBL) at the end of the 3rd month was determined and compared to the initial value. The following data were used to determine MBL: radiological marginal bone loss (RMBL), radiological implant length (RDİL), and real implant length (RİL).
Measured: İnitial to 3rt mounth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start5 Aug 2018
- Primary completion2 Oct 2020
- Study completion2 Oct 2020
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.
- More trials run by TC Erciyes 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duygu Kilic, TC Erciyes University
- Investigators
- Duygu Kılıç, Dr, Study director, Erciyes University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06322901
- Sponsor's protocol ID
- TDH-2018-7883
- Acronym
- Vertikal
- Status last verified
- Mar 2024
- First submitted
- 12 Mar 2024
- Last updated
- 21 Mar 2024
- 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 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination Of The Effect Of Vertical Releasing Incision On Implant Procedures: A Randomized Controlled Split-Mouth Study
- ClinicalTrials.gov ID
- NCT06322901
- Acronym / sponsor ID
- Vertikal / TDH-2018-7883
- Conditions
- Bone Loss, Flap Design
- Keywords
- flap design, vertical incision, OPG-RANKL, cortisol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 5 Aug 2018 (actual)
- Primary completion
- 2 Oct 2020 (actual)
- Study completion
- 2 Oct 2020 (actual)
- First posted
- 21 Mar 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.
This study evaluated the clinical and biochemical aspects of flap design in dental implant applications regarding implantation success and patient comfort. In this split-mouth randomized controlled clinical trial, a vertical releasing incision was made at the distal end of the crestal incision on the test side, and the control side received a crestal incision alone. Sixty-eight implants were placed in 17 patients. Peri-implant groove fluid was collected on postsurgical days 3, 7, 30, and 90; OPG and RANKL levels were assessed to determine bone formation and resorption around the implants. Cortisol levels were assessed in peri-implant groove fluid at postsurgical days 3, 7, and 14. Visual analog scale (VAS), and swelling measurements were taken postoperatively. Panoramic and periapical X-rays were obtained immediately post-surgery and at 3 months. No significant marginal bone loss difference was observed between the test and control sides at 3 months. The RANKL/OPG ratio, cortisol levels, VAS scores, and swelling scores were higher in the test vs. control sides. Overall, while the use of a vertical incision has advantages, such as increasing the visual field of the surgeon and improving the ease of the operation, this approach should be used only when necessary, given the disadvantages of increased bone resorption mediators in the peri-implant tissue and reduced postoperative patient comfort.
Detailed description
Dental implantation is the most widely used method for treating edentulous patients. The most important factors affecting dental implant success are the patient's systemic condition, the material used, the physical properties of the implant, and the surgical protocol. Flap design is the first and most important stage of dental implant surgery. The most commonly used surgical technique for implant placement elevates the full-thickness mucoperiosteal flap. Flap design is critical in this procedure to reduce patient pain, limit stress-related cortisol level increases, and prevent peri-implant bone loss. An ideal flap reveals the entire surgical area, allowing the surgeon to work comfortably and place the implant in the desired position; thus, a vertical incision can be added to the flap. However, recent studies have demonstrated that a minimally invasive flap design reduces postoperative pain, bleeding, crestal bone loss, and surgical time. Several other studies concluded that flap designs with or without a vertical incision are equally successful.
Marginal bone resorption also influences long-term implantation success. Marginal bone resorption is aggravated by flap design and increases in cortisol secretion due to patient pain. High cortisol and β-endorphin concentrations can significantly increase MMP-1, MMP-2, MMP-7, MMP-11, and TIMP-1 levels in human gingival fibroblasts, explaining the increase in periodontal and peri-implant destruction associated with physiological stress. Several studies have offered acceptable explanations for the relationship between oral health (especially periodontal health) and psychological stres. The pathophysiological effects of periodontal disease are directly related to host resistance and affect the immune system. A positive relationship between salivary cortisol levels and stress levels has also been observed in individuals with severe periodontal disease. Marginal bone resorption around implants can be measured biochemically by examining substances in the peri-implant crevicular fluid, such as the markers osteoprotegerin (OPG) and receptor-activator NFkB ligand (RANKL). RANKL is a membrane-bound factor expressed on the outer surfaces of osteoblast cells and plays a central role in osteoclast cell formation and development. OPG binds to RANKL and prevents it from interacting with its receptor, NFkB, on osteoclasts and preosteoclasts, preventing bone loss. The OPG/RANKL ratio in the peri-implant groove fluid can indicate marginal bone resorption around dental implants; healthy implants demonstrate greater OPG/RANKL ratios than those with active marginal bone resorption. Thus, the effects of flap design on marginal bone loss (MBL) can be compared via the OPG/RANKL ratio.
Pain also causes systemic changes. The levels of cortisol, dehydroepiandrosterone, testosterone, and thyroid-stimulating hormone in bodily fluids can indicate a patient's pain level. Cortisol is controlled by adrenocorticotropic hormone (ACTH) released from the anterior pituitary gland. Most physical or neurological stressors strongly increase ACTH secretion, and dental stress increases bodily fluid hormone levels.
A literature review revealed insufficient studies examining the effects of a vertical incision on the peri-implant bone level. Existing studies only include clinical or radiological evaluations. This study aimed to evaluate the clinical effects of flap design and incision on dental implants by administering a visual analog scale (VAS) questionnaire, measuring swelling, recording the flap surgery duration, assessing the OPG/RANKL ratio and cortisol levels in the peri-implant groove fluid, and taking periapical X-ray images. Our study is unique and comprehensive since it addresses the clinical, biochemical, and radiological effects of a vertical incision on implants. In addition, although various studies have included cortisol measurements in the gingival crevicular fluid, few have measured cortisol in peri-implant groove fluid. Our findings suggest that flap designs with a vertical incision cause early marginal bone loss and additional stress on dental implant recipients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test side | Experimental | Procedure: FlapA mid-crestal incision was made on the test side with a no. 12 scalpel and a sulcular incision was made around the first natural tooth and a 5-mm vertical incision was made disto-obliquely to the distal crestal incision |
| control side | Active comparator | Procedure: FlapOnly a mid-crestal incision was made on the control side with a no. 12 scalpel and a sulcular incision was made around the first natural tooth |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with bilateral tooth deficiency in the lower jaw posterior region who received 2 dental implants on the right and left sides were recruited from the Erciyes University Faculty of Dentistry Department of Periodontology between December 2018 and January 2020
Key exclusion criteria (1 listed)
- Patients were excluded if they had any systemic disease, demonstrated bone structure unsuitable for a 3.7 × 10 mm dental implant, were pregnant, had previously received radiotherapy or chemotherapy, had a tooth extracted from the implant area within 6 months, had active periodontal disease, required antibiotic prophylaxis, had inadequate keratinized gingiva, or demonstrated a tissue phenotype >2 mm.
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 |
|---|---|---|
| FlapDifferent flap designs for implant placement | Procedure or surgery | control side, test side |
Primary outcome
Bone loss
Time frame: İnitial to 3rt mounth
The degree of marginal bone loss (MBL) at the end of the 3rd month was determined and compared to the initial value. The following data were used to determine MBL: radiological marginal bone loss (RMBL), radiological implant length (RDİL), and real implant length (RİL).
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 21 Mar 2024.
- 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.
Duygu Kılıç, Dr study director
Erciyes University Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flap in people with Bone Loss and Flap Design, run by TC Erciyes University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 21 Mar 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 Turkey (Türkiye). 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?
Bone loss (time frame: İnitial to 3rt mounth). 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 21 Mar 2024.