Peri-implant MucositisNCT06173739
Peri-implant Phenotype, Calprotectin and Mmp-8 Levels in Cases Diagnosed With Peri-implant Disease
A study testing Non-surgical mechanical treatment in people with Peri-implant Mucositis and Peri-Implantitis, run by Beliz Önder at 1 site in Turkey (Türkiye).
Trial summary
Following the implantation procedures; The peri-implant mucosa may begin to show signs of inflammation depending on the patient (bruxism, lack of oral hygiene) or other factors (planning errors, iatrogenic factors). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Peri-implant Mucositis, Peri-Implantitis
- What is being tested?
- Non-surgical mechanical treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Aug 2020to 22 Mar 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Systemically healthy,
- Non-smoker,
- There is no drug allergy and no advanced surgical techniques are required.
- 39 volunteers, aged 18-65, who applied to the Department of Periodontics with complaints of infection around the implant or were referred to our clinic, will be included.
Who cannot join
- Any drug allergy,
- Pregnant or breastfeeding,
- smoker
- Having a systemic disability,
- Peri-implant disease requiring advanced surgical techniques for treatment
- Individuals who are not volunteers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Peri-Implant Soft Tissue Phenotype on the Severity of Peri-Implant Diseases and the Outcomes of Non-Surgical Mechanical Treatment
Following the implantation procedures; The peri-implant mucosa may begin to show signs of inflammation depending on the patient (bruxism, lack of oral hygiene) or other factors (planning errors, iatrogenic factors). These signs of inflammation may remain limited to soft tissue or may progress to bone depending on the host response. Another relevant factor in such cases is peri-implant mucosa thickness. Our study aims to investigate the effect of peri-implant soft tissue thickness on the degree of peri-implant disease and the contribution of soft tissue augmentation procedures applied with subepithelial connective tissue graft and non-surgical mechanical treatment results, accompanied by clinical and biochemical parameters.
Read the detailed description
The study was carried out in Van Yüzüncü Yıl University Faculty of Dentistry, in patients who were diagnosed with inflammation or bone loss around their implants and were referred to Periodontology Department for the treatment of the relevant areas, aged between 18-65, systemically healthy, non-smokers, and without any drug allergies. and will be conducted on 50 volunteer individuals who do not require advanced surgical techniques. The peri-implant soft tissue phenotype of all participants who are detected to have peri-implant disease and will be included in the study will be measured, necessary clinical and radiological examinations will be performed, necessary samples will be collected and conventional mechanical treatments will be applied. The data of all participants will be collected again in the 6th month following the treatment. Study details are given below: Patients who will participate in the study will be explained the details of the application and the research to be conducted and will have to sign an informed consent form.
Detailed anamnesis of patients who meet the selection criteria will be taken and clinical and radiological examinations will be performed. Patients with caries on their teeth will be directed to Restorative Dentistry Department and restorations of existing caries will be made at the relevant clinic. Patients will be given oral hygiene training before the mechanical treatment of peri-implant diseases.
Peri-implant crevice fluid (PICF) samples will be collected before mechanical treatment of the diseased implant areas of individuals is initiated. The areas will be isolated from saliva with cotton pellets, dried with light air, and the paper strips will be kept in the trough for 30 seconds. Paper strips obtained from each implant will be placed in Eppendorf tubes containing isotonic Ph:7.4 phosphate buffer solution and stored at -40 ° C until analyzed in the laboratory department of our clinic.
Routine periodontal parameters such as plaque index, gingival index, bleeding on probing, probing pocket depth, and clinical attachment level of the individuals whose PICF samples are collected will be measured and recorded with the help of Williams-type plastic probes.
Following these procedures, the patients; peri-implant phenotype will be evaluated. In the evaluation, the traditional transgingival probing technique and a newly developed technique will be used simultaneously and their correlations with each other will be examined. In the transgingival probing technique, measurements will be made from two points: apical of the free gingival groove and coronal of the mucogingival composition. After the peri-implant mucosa thickness measurement points are determined with a marker pen, Xylocaine® spray (Vemcaine 10%, lidocaine) or, if necessary, local anesthetic (Maxicaine, lidocaine hydrochloride) will be applied to prevent the patient from feeling pain. Measurements will be made from the marked points in a direction perpendicular to the peri-implant mucosa, using a 10-gauge endodontic spreader (G-Star Medical Co., Ltd., Guangdong, China) with a silicone stopper until its contact with the alveolar bone is felt. Since excessive force will cause the spreader to exceed the soft tissue and advance in the alveolar bone, care should be taken to apply only light forces that can be limited to the soft tissue. After all measurements are repeated twice by the same researcher at 10-minute intervals, the amount of peri-implant mucosa thickness in each region will be determined by taking the average of the two measurements. If the millimetric values obtained as a result of measurements are less than 1 mm, thin phenotype; If it is more than 1 mm, it will be classified as thick phenotype. The second gingival phenotype evaluation in individuals with peri-implant disease will be performed with the Hu-Friedy Colorvue Biotip Probe®, a newly developed probe with a colored tip that will be placed in the peri-implant pocket. The white probe will first be placed in the peri-implant pocket with a pressure of less than 25 N. If the color of the probe reflects from the gingival tissue, the phenotype will be recorded as thin. If the white color is not visible, the green probe will be placed in the pocket in the same way and if the color is reflected, the phenotype will be classified as medium thickness. If the Green tip is not visible through the gingival tissue, the Blue probe will be used and if the only color seen is Blue, the phenotype will be classified as thick. If blue is not visible, the peri-implant mucosa tissue will be recorded as too thick.
Then, traditional mechanical debridement with titanium curettes will be applied to areas with peri-implant disease. The area will be irrigated with physiological saline from time to time. Following the procedure, patients will be called for control at the 1st, 3rd and 6th months. Oral hygiene instructions will be repeated when necessary. At the 6th month, all clinical parameters examined will be measured again and PICF samples will be collected again.
All procedures will be performed by the same researcher. After the target number of patients is reached, the PICF samples collected will be sent to the laboratory for analysis using ELISA (Enzyme-linked immunosorbent assay) kits. Statistical analysis will be performed and interpreted for the features emphasized.
- Conditions
- Peri-implant Mucositis, Peri-Implantitis
- Being tested
- Non-surgical mechanical treatment
- Keywords
- peri-implant disease, calprotectin, phenotype
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-surgical mechanical treatmentProcedure or surgery
Nonsurgical mechanical therapy (NSMT) aims to control infection and minimize bacterial burden through debridement of the implant surface. It is the gold standard treatment method for both peri-implantitis and peri-implant mucositis.
Non-surgical mechanical treatment will be applied to patients with the purpose of surface debridement and reducing bacterial flora in implants with peri-implant disease for which clinical examination has been completed and the diagnosis has been confirmed. All intraoral implants of the patients will be evaluated and all implants that do not meet the clinical definition of health will be intervened. Each implant surface will be treated with a titanium curette. In all groups, mechanical debridement was performed on the surfaces by the same clinician.
The procedure will continue gently until it is felt that it has been adequately debrided. Subgingival irrigation will be performed with physiological saline. Post NSMT No medication will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Peri-implant mucositis | Active comparator | It is defined as widespread inflammatory disease of the soft tissue surrounding endosseous implants without loss of crestal bone or marginal bone. Peri-implant mucositis is diagnosed by pain, swelling, redness and bleeding on probing in the soft tissue around the dental implant.
Diagnosis will be completed based on radiographic and clinical findings at the first encounter with the patient.
In the second session, PICF (peri-implant crevicular fluid) will be collected from both groups of implants and phenotype evaluations will be made.
Following the recording of clinical parameters (PD, GI, PI, CAL, BOP), non-surgical mechanical treatment will be applied to both groups. Receives: Procedure: Non-surgical mechanical treatment |
| Peri-implantitis | Active comparator | Peri-implantitis is a pathology that occurs in the tissues around dental implants, characterized by inflammation of the peri-implant mucosa and destruction of marginal and crestal bone. Clinical diagnosis is defined by the presence of bleeding on probing, the presence of pathological pockets, exudate, swelling, edema, and hyperemia, while findings of bone loss are supported by radiography.
Diagnosis will be completed based on radiographic and clinical findings at the first encounter with the patient.
In the second session, PICF (peri-implant crevicular fluid) will be collected from both groups of implants and phenotype evaluations will be made.
Following the recording of clinical parameters (PD, GI, PI, CAL, BOP), non-surgical mechanical treatment will be applied to both groups. Receives: Procedure: Non-surgical mechanical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing Depth(PD)
The depth of the peri-implant pocket or groove was measured with a plastic probe (KERR- Hawe Caliber Plastic Periodontal Probe, Switzerland) from 4 regions of the peri-implant mucosa: mesial, distal, lingual/palatinal and buccal. No extra force was applied to the plastic probe during measurement. The probe placed in the pocket was held parallel to the abutment with a force equal to its own weight (approximately 0.25 N). At the point where resistance is felt at the bottom of the pocket without losing contact with the implant surface; The value corresponding to the margin was recorded on the plastic probe (KERR- Hawe Caliber Plastic Periodontal Probe, Switzerland). All measurement values were collected and averaged, and the average probing depth of the relevant implant was determined.
Measured: Immediately before procedure
Probing Depth(PD)
The depth of the peri-implant pocket or groove was measured with a plastic probe (KERR- Hawe Caliber Plastic Periodontal Probe, Switzerland) from 4 regions of the peri-implant mucosa: mesial, distal, lingual/palatinal and buccal. No extra force was applied to the plastic probe during measurement. The probe placed in the pocket was held parallel to the abutment with a force equal to its own weight (approximately 0.25 N). At the point where resistance is felt at the bottom of the pocket without losing contact with the implant surface; The value corresponding to the margin was recorded on the plastic probe (KERR- Hawe Caliber Plastic Periodontal Probe, Switzerland). All measurement values were collected and averaged, and the average probing depth of the relevant implant was determined.
Measured: After 6 months procedure
Gingival Index (GI)
The plastic probe (KERR- Hawe Caliber Plastic Periodontal Probe, Switzerland) is placed in the groove or pocket without pressure.
bleeding from 4 regions (mesial, distal, lingual/palatinal and buccal) scoring was done. The gingival index score for the relevant implant is the total value Obtained by taking the average. Gingival index, inflammation in the peri-implant mucosa is one of the important indicators.
Measured: Immediately before procedure
Gingival Index (GI)
The plastic probe (KERR- Hawe Caliber Plastic Periodontal Probe, Switzerland) is placed in the groove or pocket without pressure.
bleeding from 4 regions (mesial, distal, lingual/palatinal and buccal) scoring was done. The gingival index score for the relevant implant is the total value Obtained by taking the average. Gingival index, inflammation in the peri-implant mucosa is one of the important indicators.
Measured: After 6 months procedure
Plaque Index(PI)
The area around the abutment to be measured was isolated with cotton pads and gently dried with air-water spray.
Plaque was collected from around the groove or pocket with the help of a plastic probe (KERR- Hawe Caliber Plastic Periodontal Probe, Switzerland).
Measured: Immediately before procedure
Plaque Index(PI)
The area around the abutment to be measured was isolated with cotton pads and gently dried with air-water spray.
Plaque was collected from around the groove or pocket with the help of a plastic probe (KERR- Hawe Caliber Plastic Periodontal Probe, Switzerland).
Measured: After 6 months procedure
Bleeding on Probing (BOP)
The bleeding on probing score is the gold standard for detecting peri-implant diseases. If bleeding occurs after the probe is placed in the pocket, it is scored as positive (+), otherwise it is scored as negative (-).
Measured: Immediately before procedure
Bleeding on Probing (BOP)
The bleeding on probing score is the gold standard for detecting peri-implant diseases. If bleeding occurs after the probe is placed in the pocket, it is scored as positive (+), otherwise it is scored as negative (-).
Measured: After 6 months procedure
Clinical Attachment Level (CAL)
CAL; It is defined as the distance from the cemento-enamel junction (CEJ) on tooth surfaces to the apical of the pocket base. In the presence of gingival recession; The gingival margin migrates apical to the CEJ. In this case, CAL; length of gingival recession and probing It is calculated as the sum of the depth.
Measured: Immediately before procedure
Clinical Attachment Level (CAL)
CAL; It is defined as the distance from the cemento-enamel junction (CEJ) on tooth surfaces to the apical of the pocket base. In the presence of gingival recession; The gingival margin migrates apical to the CEJ. In this case, CAL; length of gingival recession and probing It is calculated as the sum of the depth.
Measured: After 6 months procedure
Calprotectin (CAL)
PICFs collected from the peri-implant margin with paper strips are analyzed by ELISA method. In this method, the amount of CLP, a degradation protein, is calculated. CLP is an antimicrobial protein and inflammation marker.
Measured: Immediate before procedure
Calprotectin (CAL)
PICFs collected from the peri-implant margin with paper strips are analyzed by ELISA method. In this method, the amount of CLP, a degradation protein, is calculated. CLP is an antimicrobial protein and inflammation marker.
Measured: After 6 months procedure
Matrix Metalloproteinaz-8(MMP-8)
PICFs collected from the peri-implant margin with paper strips are analyzed by ELISA method. MMP-8 is currently used in the prediction, diagnosis, treatment prognosis and treatment of periodontal disease.
It is considered one of the main biomarkers used for classification. On the other hand, effective periodontal treatment and MMP inhibitor adjuvant drugs are effective in the progression of periodontal disease by reducing the MMP-8 level in GCF (gingival crevicular fluid) and saliva.
It has been shown to have inhibitory effects. Collagenase, which also plays a role in inflammation of peri-implant connective tissue, and gelatinases, with high levels of MMP-8 in peri-implant crevice fluid. has been associated. Low MMP-8 level was determined to indicate peri-implant health, while high regulation of MMP 8 showed inflammation.
Measured: Immediate before procedure
Matrix Metalloproteinaz-8(MMP-8)
PICFs collected from the peri-implant margin with paper strips are analyzed by ELISA method. MMP-8 is currently used in the prediction, diagnosis, treatment prognosis and treatment of periodontal disease.
It is considered one of the main biomarkers used for classification. On the other hand, effective periodontal treatment and MMP inhibitor adjuvant drugs are effective in the progression of periodontal disease by reducing the MMP-8 level in GCF (gingival crevicular fluid) and saliva.
It has been shown to have inhibitory effects. Collagenase, which also plays a role in inflammation of peri-implant connective tissue, and gelatinases, with high levels of MMP-8 in peri-implant crevice fluid. has been associated. Low MMP-8 level was determined to indicate peri-implant health, while high regulation of MMP 8 showed inflammation.
Measured: After 6 months procedure
Secondary outcomes (1)
Peri-implant phenotype
While evaluating the peri-implant tissue phenotype, peri-implant mucosa dimensions include keratinized tissue width, mucosa thickness and supracrestal tissue height; Bone level is also included in the phenotype elements.
When measuring keratinized gums; Williams probe was used. While determining the biotype, Hu-Friedy Colorvue probes were used. Mucosa thickness is; Transgingival probing measurement technique was used. Supracrestal tissue height was measured by transmucosal probing.
Measured: Before non-surgical mechanical treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start21 Aug 2020
- Primary completion22 Mar 2022
- Study completion22 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peri-implant MucositisStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beliz Önder
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Beliz Önder, Bilecik Seyh Edebali Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06173739
- Sponsor's protocol ID
- BSEU-ONDER-001
- Status last verified
- Dec 2023
- First submitted
- 24 Nov 2023
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It will be shared during the publication phase.
Publications
Berglundh T, Armitage G, Araujo MG, Avila-Ortiz G, Blanco J, Camargo PM, Chen S, Cochran D, Derks J, Figuero E, Hammerle CHF, Heitz-Mayfield LJA, Huynh-Ba G, Iacono V, Koo KT, Lambert F, McCauley L, Quirynen M, Renvert S, Salvi GE, Schwarz F, Tarnow D, Tomasi C, Wang HL, Zitzmann N. Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Periodontol. 2018 Jun;89 Suppl 1:S313-S318. doi: 10.1002/JPER.17-0739.
PubMed 29926955Onder YB, Alpaslan NZ. Peri-implant phenotype, calprotectin and MMP-8 levels in cases diagnosed with peri-implant disease. Clin Oral Investig. 2024 Jun 28;28(7):404. doi: 10.1007/s00784-024-05798-w.
PubMed 38940878
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Peri-Implant Soft Tissue Phenotype on the Severity of Peri-Implant Diseases and the Outcomes of Non-Surgical Mechanical Treatment
- ClinicalTrials.gov ID
- NCT06173739
- Acronym / sponsor ID
- BSEU-ONDER-001
- Conditions
- Peri-implant Mucositis, Peri-Implantitis
- Keywords
- peri-implant disease, calprotectin, phenotype
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Beliz ÖnderUniversity, hospital or other
- Study start
- 21 Aug 2020 (actual)
- Primary completion
- 22 Mar 2022 (actual)
- Study completion
- 22 Mar 2022 (actual)
- First posted
- 18 Dec 2023 (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.
Following the implantation procedures; The peri-implant mucosa may begin to show signs of inflammation depending on the patient (bruxism, lack of oral hygiene) or other factors (planning errors, iatrogenic factors). These signs of inflammation may remain limited to soft tissue or may progress to bone depending on the host response. Another relevant factor in such cases is peri-implant mucosa thickness. Our study aims to investigate the effect of peri-implant soft tissue thickness on the degree of peri-implant disease and the contribution of soft tissue augmentation procedures applied with subepithelial connective tissue graft and non-surgical mechanical treatment results, accompanied by clinical and biochemical parameters.
Detailed description
The study was carried out in Van Yüzüncü Yıl University Faculty of Dentistry, in patients who were diagnosed with inflammation or bone loss around their implants and were referred to Periodontology Department for the treatment of the relevant areas, aged between 18-65, systemically healthy, non-smokers, and without any drug allergies. and will be conducted on 50 volunteer individuals who do not require advanced surgical techniques. The peri-implant soft tissue phenotype of all participants who are detected to have peri-implant disease and will be included in the study will be measured, necessary clinical and radiological examinations will be performed, necessary samples will be collected and conventional mechanical treatments will be applied. The data of all participants will be collected again in the 6th month following the treatment. Study details are given below: Patients who will participate in the study will be explained the details of the application and the research to be conducted and will have to sign an informed consent form.
Detailed anamnesis of patients who meet the selection criteria will be taken and clinical and radiological examinations will be performed. Patients with caries on their teeth will be directed to Restorative Dentistry Department and restorations of existing caries will be made at the relevant clinic. Patients will be given oral hygiene training before the mechanical treatment of peri-implant diseases.
Peri-implant crevice fluid (PICF) samples will be collected before mechanical treatment of the diseased implant areas of individuals is initiated. The areas will be isolated from saliva with cotton pellets, dried with light air, and the paper strips will be kept in the trough for 30 seconds. Paper strips obtained from each implant will be placed in Eppendorf tubes containing isotonic Ph:7.4 phosphate buffer solution and stored at -40 ° C until analyzed in the laboratory department of our clinic.
Routine periodontal parameters such as plaque index, gingival index, bleeding on probing, probing pocket depth, and clinical attachment level of the individuals whose PICF samples are collected will be measured and recorded with the help of Williams-type plastic probes.
Following these procedures, the patients; peri-implant phenotype will be evaluated. In the evaluation, the traditional transgingival probing technique and a newly developed technique will be used simultaneously and their correlations with each other will be examined. In the transgingival probing technique, measurements will be made from two points: apical of the free gingival groove and coronal of the mucogingival composition. After the peri-implant mucosa thickness measurement points are determined with a marker pen, Xylocaine® spray (Vemcaine 10%, lidocaine) or, if necessary, local anesthetic (Maxicaine, lidocaine hydrochloride) will be applied to prevent the patient from feeling pain. Measurements will be made from the marked points in a direction perpendicular to the peri-implant mucosa, using a 10-gauge endodontic spreader (G-Star Medical Co., Ltd., Guangdong, China) with a silicone stopper until its contact with the alveolar bone is felt. Since excessive force will cause the spreader to exceed the soft tissue and advance in the alveolar bone, care should be taken to apply only light forces that can be limited to the soft tissue. After all measurements are repeated twice by the same researcher at 10-minute intervals, the amount of peri-implant mucosa thickness in each region will be determined by taking the average of the two measurements. If the millimetric values obtained as a result of measurements are less than 1 mm, thin phenotype; If it is more than 1 mm, it will be classified as thick phenotype. The second gingival phenotype evaluation in individuals with peri-implant disease will be performed with the Hu-Friedy Colorvue Biotip Probe®, a newly developed probe with a colored tip that will be placed in the peri-implant pocket. The white probe will first be placed in the peri-implant pocket with a pressure of less than 25 N. If the color of the probe reflects from the gingival tissue, the phenotype will be recorded as thin. If the white color is not visible, the green probe will be placed in the pocket in the same way and if the color is reflected, the phenotype will be classified as medium thickness. If the Green tip is not visible through the gingival tissue, the Blue probe will be used and if the only color seen is Blue, the phenotype will be classified as thick. If blue is not visible, the peri-implant mucosa tissue will be recorded as too thick.
Then, traditional mechanical debridement with titanium curettes will be applied to areas with peri-implant disease. The area will be irrigated with physiological saline from time to time. Following the procedure, patients will be called for control at the 1st, 3rd and 6th months. Oral hygiene instructions will be repeated when necessary. At the 6th month, all clinical parameters examined will be measured again and PICF samples will be collected again.
All procedures will be performed by the same researcher. After the target number of patients is reached, the PICF samples collected will be sent to the laboratory for analysis using ELISA (Enzyme-linked immunosorbent assay) kits. Statistical analysis will be performed and interpreted for the features emphasized.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peri-implant mucositis | Active comparator | Procedure: Non-surgical mechanical treatmentIt is defined as widespread inflammatory disease of the soft tissue surrounding endosseous implants without loss of crestal bone or marginal bone. Peri-implant mucositis is diagnosed by pain, swelling, redness and bleeding on probing in the soft tissue around the dental implant. Diagnosis will be completed based on radiographic and clinical findings at the first encounter with the patient. In the second session, PICF (peri-implant crevicular fluid) will be collected from both groups of implants and phenotype evaluations will be made. Following the recording of clinical parameters (PD, GI, PI, CAL, BOP), non-surgical mechanical treatment will be applied to both groups. |
| Peri-implantitis | Active comparator | Procedure: Non-surgical mechanical treatmentPeri-implantitis is a pathology that occurs in the tissues around dental implants, characterized by inflammation of the peri-implant mucosa and destruction of marginal and crestal bone. Clinical diagnosis is defined by the presence of bleeding on probing, the presence of pathological pockets, exudate, swelling, edema, and hyperemia, while findings of bone loss are supported by radiography. Diagnosis will be completed based on radiographic and clinical findings at the first encounter with the patient. In the second session, PICF (peri-implant crevicular fluid) will be collected from both groups of implants and phenotype evaluations will be made. Following the recording of clinical parameters (PD, GI, PI, CAL, BOP), non-surgical mechanical treatment will be applied to both groups. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- -Systemically healthy,
- Non-smoker,
- There is no drug allergy and no advanced surgical techniques are required.
- 39 volunteers, aged 18-65, who applied to the Department of Periodontics with complaints of infection around the implant or were referred to our clinic, will be included.
Key exclusion criteria (6 listed)
- Any drug allergy,
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 |
|---|---|---|
| Non-surgical mechanical treatmentNonsurgical mechanical therapy (NSMT) aims to control infection and minimize bacterial burden through debridement of the implant surface. It is the gold standard treatment method for both peri-implantitis and peri-implant mucositis. Non-surgical mechanical treatment will be applied to patients with the purpose of surface debridement and reducing bacterial flora in implants with peri-implant disease for which clinical examination has been completed and the diagnosis has been confirmed. All intraoral implants of the patients will be evaluated and all implants that do not meet the clinical definition of health will be intervened. Each implant surface will be treated with a titanium curette. In all groups, mechanical debridement was performed on the surfaces by the same clinician. The procedure will continue gently until it is felt that it has been adequately debrided. Subgingival irrigation will be performed with physiological saline. Post NSMT No medication will be administered. | Procedure or surgery | Peri-implant mucositis, Peri-implantitis |
Primary outcome
Probing Depth(PD)
Time frame: Immediately before procedure
The depth of the peri-implant pocket or groove was measured with a plastic probe (KERR- Hawe Caliber Plastic Periodontal Probe, Switzerland) from 4 regions of the peri-implant mucosa: mesial, distal, lingual/palatinal and buccal. No extra force was applied to the plastic probe during measurement. The probe placed in the pocket was held parallel to the abutment with a force equal to its own weight (approximately 0.25 N). At the point where resistance is felt at the bottom of the pocket without losing contact with the implant surface; The value corresponding to the margin was recorded on the plastic probe (KERR- Hawe Caliber Plastic Periodontal Probe, Switzerland). All measurement values were collected and averaged, and the average probing depth of the relevant implant was determined.
Probing Depth(PD)
Time frame: After 6 months procedure
The depth of the peri-implant pocket or groove was measured with a plastic probe (KERR- Hawe Caliber Plastic Periodontal Probe, Switzerland) from 4 regions of the peri-implant mucosa: mesial, distal, lingual/palatinal and buccal. No extra force was applied to the plastic probe during measurement. The probe placed in the pocket was held parallel to the abutment with a force equal to its own weight (approximately 0.25 N). At the point where resistance is felt at the bottom of the pocket without losing contact with the implant surface; The value corresponding to the margin was recorded on the plastic probe (KERR- Hawe Caliber Plastic Periodontal Probe, Switzerland). All measurement values were collected and averaged, and the average probing depth of the relevant implant was determined.
Gingival Index (GI)
Time frame: Immediately before procedure
The plastic probe (KERR- Hawe Caliber Plastic Periodontal Probe, Switzerland) is placed in the groove or pocket without pressure. bleeding from 4 regions (mesial, distal, lingual/palatinal and buccal) scoring was done. The gingival index score for the relevant implant is the total value Obtained by taking the average. Gingival index, inflammation in the peri-implant mucosa is one of the important indicators.
Gingival Index (GI)
Time frame: After 6 months procedure
The plastic probe (KERR- Hawe Caliber Plastic Periodontal Probe, Switzerland) is placed in the groove or pocket without pressure. bleeding from 4 regions (mesial, distal, lingual/palatinal and buccal) scoring was done. The gingival index score for the relevant implant is the total value Obtained by taking the average. Gingival index, inflammation in the peri-implant mucosa is one of the important indicators.
Plaque Index(PI)
Time frame: Immediately before procedure
The area around the abutment to be measured was isolated with cotton pads and gently dried with air-water spray. Plaque was collected from around the groove or pocket with the help of a plastic probe (KERR- Hawe Caliber Plastic Periodontal Probe, Switzerland).
Plaque Index(PI)
Time frame: After 6 months procedure
The area around the abutment to be measured was isolated with cotton pads and gently dried with air-water spray. Plaque was collected from around the groove or pocket with the help of a plastic probe (KERR- Hawe Caliber Plastic Periodontal Probe, Switzerland).
Bleeding on Probing (BOP)
Time frame: Immediately before procedure
The bleeding on probing score is the gold standard for detecting peri-implant diseases. If bleeding occurs after the probe is placed in the pocket, it is scored as positive (+), otherwise it is scored as negative (-).
Bleeding on Probing (BOP)
Time frame: After 6 months procedure
The bleeding on probing score is the gold standard for detecting peri-implant diseases. If bleeding occurs after the probe is placed in the pocket, it is scored as positive (+), otherwise it is scored as negative (-).
Clinical Attachment Level (CAL)
Time frame: Immediately before procedure
CAL; It is defined as the distance from the cemento-enamel junction (CEJ) on tooth surfaces to the apical of the pocket base. In the presence of gingival recession; The gingival margin migrates apical to the CEJ. In this case, CAL; length of gingival recession and probing It is calculated as the sum of the depth.
Clinical Attachment Level (CAL)
Time frame: After 6 months procedure
CAL; It is defined as the distance from the cemento-enamel junction (CEJ) on tooth surfaces to the apical of the pocket base. In the presence of gingival recession; The gingival margin migrates apical to the CEJ. In this case, CAL; length of gingival recession and probing It is calculated as the sum of the depth.
Calprotectin (CAL)
Time frame: Immediate before procedure
PICFs collected from the peri-implant margin with paper strips are analyzed by ELISA method. In this method, the amount of CLP, a degradation protein, is calculated. CLP is an antimicrobial protein and inflammation marker.
Calprotectin (CAL)
Time frame: After 6 months procedure
PICFs collected from the peri-implant margin with paper strips are analyzed by ELISA method. In this method, the amount of CLP, a degradation protein, is calculated. CLP is an antimicrobial protein and inflammation marker.
Matrix Metalloproteinaz-8(MMP-8)
Time frame: Immediate before procedure
PICFs collected from the peri-implant margin with paper strips are analyzed by ELISA method. MMP-8 is currently used in the prediction, diagnosis, treatment prognosis and treatment of periodontal disease. It is considered one of the main biomarkers used for classification. On the other hand, effective periodontal treatment and MMP inhibitor adjuvant drugs are effective in the progression of periodontal disease by reducing the MMP-8 level in GCF (gingival crevicular fluid) and saliva. It has been shown to have inhibitory effects. Collagenase, which also plays a role in inflammation of peri-implant connective tissue, and gelatinases, with high levels of MMP-8 in peri-implant crevice fluid. has been associated. Low MMP-8 level was determined to indicate peri-implant health, while high regulation of MMP 8 showed inflammation.
Matrix Metalloproteinaz-8(MMP-8)
Time frame: After 6 months procedure
PICFs collected from the peri-implant margin with paper strips are analyzed by ELISA method. MMP-8 is currently used in the prediction, diagnosis, treatment prognosis and treatment of periodontal disease. It is considered one of the main biomarkers used for classification. On the other hand, effective periodontal treatment and MMP inhibitor adjuvant drugs are effective in the progression of periodontal disease by reducing the MMP-8 level in GCF (gingival crevicular fluid) and saliva. It has been shown to have inhibitory effects. Collagenase, which also plays a role in inflammation of peri-implant connective tissue, and gelatinases, with high levels of MMP-8 in peri-implant crevice fluid. has been associated. Low MMP-8 level was determined to indicate peri-implant health, while high regulation of MMP 8 showed inflammation.
1 secondary outcome
Peri-implant phenotype
Time frame: Before non-surgical mechanical treatment
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 18 Dec 2023.
- Background: PubMed 29926955Berglundh T, Armitage G, Araujo MG, Avila-Ortiz G, Blanco J, Camargo PM, Chen S, Cochran D, Derks J, Figuero E, Hammerle CHF, Heitz-Mayfield LJA, Huynh-Ba G, Iacono V, Koo KT, Lambert F, McCauley L, Quirynen M, Renvert S, Salvi GE, Schwarz F, Tarnow D, Tomasi C, Wang HL, Zitzmann N. Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Periodontol. 2018 Jun;89 Suppl 1:S313-S318. doi: 10.1002/JPER.17-0739.
- Derived from this study: PubMed 38940878Onder YB, Alpaslan NZ. Peri-implant phenotype, calprotectin and MMP-8 levels in cases diagnosed with peri-implant disease. Clin Oral Investig. 2024 Jun 28;28(7):404. doi: 10.1007/s00784-024-05798-w.
- Individual participant dataSharing planned: No. It will be shared during the publication phase.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-surgical mechanical treatment in people with Peri-implant Mucositis and Peri-Implantitis, run by Beliz Önder 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 4 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 18 Dec 2023. 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?
Probing Depth(PD) (time frame: Immediately before procedure). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06173739, which also lists 2 linked publications.
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 18 Dec 2023.