Peri-implant Phenotype, Calprotectin and Mmp-8 Levels in Cases Diagnosed With Peri-implant Disease

NCT06173739 | Completed

• 1 other identifier: BSEU-ONDER-001
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Peri-implant Mucositis; Peri-Implantitis

Keywords

peri-implant disease; calprotectin; phenotype

Outcome Measures

Primary Outcomes (14)

• 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.

  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.

  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.

  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.

  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).

  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).

  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 (-).

  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 (-).

  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.

  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.

  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.

  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.

  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.

  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.

  After 6 months procedure

Secondary Outcomes (1)

• Peri-implant phenotype

  Before non-surgical mechanical treatment

Study Arms (2)

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.

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.

Procedure: Non-surgical mechanical treatment

Interventions

Non-surgical mechanical treatment PROCEDURE

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.

Peri-implant mucositis; Peri-implantitis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Systemically healthy,
• Non-smoker,
• There is no drug allergy and no advanced surgical techniques are required.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Beliz Önder: lead

Study Sites (1)

Van Yüzüncü Yıl Unıversity

Van, 65080, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 29926955 BACKGROUND

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 24, 2023
• First Posted: December 18, 2023
• Study Start: August 21, 2020
• Primary Completion: March 22, 2022
• Study Completion: March 22, 2022
• Last Updated: December 18, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)