Peri-Implant Soft Tissue and Health (PSTH)

Peri-Implant Soft Tissue and Peri-Implant Health

Implant patients who applied to Bolu Abant İzzet Baysal University provided anamnesis. The study included 165 people with 272 implants. The study includes implants that satisfied the inclusion criteria. Plaque index (PI) [13], gingival index (GI) [14], bleeding on probing (BOP) [15], periodontal pocket depth (PPD), clinical attachment level (CAL), gingival recession (GR), GP, GT, and KTW were all assessed in every implant patient. The presence of peri-implant mucositis or peri-implant health was assessed using the collected indices and radiographs. The patients were split into two groups: those with peri-implant mucositis (136 implants) and those with peri-implant health (136 implants). We investigated the relationships between each parameter and periodontal health.

Study Overview

• Status: Completed
• Conditions: Peri Implant Mucositis
• Intervention / Treatment: Other: Implant

• Study Type: Observational
• Enrollment (Actual): 272

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Turkey
    • Bolu, Turkey, Turkey (Türkiye), 14300
      • Bolu abant Izzet Baysal University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients who have received implants

Description

Inclusion Criteria:

• Patients aged 18-65 years who were systemically healthy, had a controlled medical conditions, and had fixed prostheses on the implants for at least 1 year following functional prosthetic loading of the dental implants.

Exclusion Criteria:

• Individuals with bruxism; those who smoke, were pregnant, or were breastfeeding; those who used anti-inflammatory drugs, immunosuppressants, or medications affecting the mucosa and bone; those who had undergone peri-implant disease treatment after implant placement; and those with residual cement residue and peri-implantitis related to prosthesis design or incorrectly placed implants.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Peri-implant mucositis; In the absence of bone loss, peri-implant mucositis refers to inflammation of the mucosa surrounding endosseous tissue	Other: Implant; The classification of peri-implant diseases is based on clinical and radiographic criteria, distinguishing between peri-implant mucositis and peri-implantitis according to the presence of inflammation and bone loss.
Periodontal health; Peri-implant health is characterized by the absence of erythema, bleeding on probing, swelling, and suppuration, and is synonymous with implant success	Other: Implant; The classification of peri-implant diseases is based on clinical and radiographic criteria, distinguishing between peri-implant mucositis and peri-implantitis according to the presence of inflammation and bone loss.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gingival phenotype	If the probe was visible when placed in the sulcus, gingiva was classified as thin (≤1 mm), and if the reflection of the probe was not visible, it was classified as thick (> 1 mm).	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gingival recession	Gingival recession is the measured distance between the enamel-cementum and the gingival margin. Assessment was performed using a Williams periodontal probe.	Baseline
Periodontal pocket depth	The periodontal pocket depth is the measurement of the distance between the gingival margin and the most coronal region of the junctional epithelium.	Baseline
Bleeding on probing	The bleeding on probing index was established as the occurrence of bleeding in the sulcus, thirty seconds after measuring the depth of the periodontal pockets in all dental implant.	Baseline
Plaque index	An index for estimating the status of oral hygiene by measuring dental plaque that occurs in the areas adjacent to the gingival margin. 0 is minimum and 3 is maximum. The situation worsens as the score increases.	Baseline
Gingival index	The Gingival Index (GI) scores each site on a 0 to 3 scale, with 0 being normal and 3 being severe inflammation characterized by edema, redness, swelling, and spontaneous bleeding. 0 is minimum and 3 is maximum.	Baseline
Clinical attachment level	The peri-implant clinical attachment level is determined by measuring the distance from the implant margin to the base of the mucosal sulcus using a Williams periodontal probe.	Baseline
Gingival thickness	GT was measured by inserting a number eight canal file from the buccal side of the implant until it reached the alveolar bone and then securing it with a stopper to determine the distance.	Baseline
Keratinized tissue width	The width of the keratinized gingiva was measured via a periodontal probe from the mucogingival margin to the gingival margin.	Baseline

Collaborators and Investigators

• Sponsor: Tuğba ŞAHİN
• Investigators: Principal Investigator: TUGBA SAHIN, Abant Izzet Baysal University

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2024
• Primary Completion (Actual): March 2, 2026
• Study Completion (Actual): March 3, 2026

Study Registration Dates

• First Submitted: April 27, 2026
• First Submitted That Met QC Criteria: April 27, 2026
• First Posted (Actual): May 4, 2026

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Gingiva; Dental Implants; Peri-implant tissue
• Additional Relevant MeSH Terms: Pharmaceutical Preparations; Dosage Forms; Delayed-Action Preparations; Drug Implants
• Other Study ID Numbers: BAIBU-DH-TS-07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No