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Completed

NCT Number: NCT07564687

Peri-Implant Soft Tissue and 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.

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Key information

Conditions

Peri Implant Mucositis

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bolu Abant İzzet Baysal University

Bolu, Turkey, 14300, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Implant

Other

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.

Primary outcomes

  1. Gingival phenotype

    Time frame: Baseline

    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).

Secondary outcomes

  1. Periodontal pocket depth

    Time frame: Baseline

    The periodontal pocket depth is the measurement of the distance between the gingival margin and the most coronal region of the junctional epithelium.

  2. Bleeding on probing

    Time frame: Baseline

    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.

  3. Plaque index

    Time frame: Baseline

    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.

  4. Gingival index

    Time frame: Baseline

    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.

  5. Clinical attachment level

    Time frame: Baseline

    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.

  6. Gingival recession

    Time frame: Baseline

    Gingival recession is the measured distance between the enamel-cementum and the gingival margin. Assessment was performed using a Williams periodontal probe.

  7. Gingival thickness

    Time frame: Baseline

    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.

  8. Keratinized tissue width

    Time frame: Baseline

    The width of the keratinized gingiva was measured via a periodontal probe from the mucogingival margin to the gingival margin.

Sponsors and collaborators

Lead sponsor

Tuğba ŞAHİN

Other

Registry information

Official study title

Peri-Implant Soft Tissue and Peri-Implant Health

Acronym: PSTH

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 4, 2026
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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