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NCT Number: NCT05073952

Keratized Mucosa in CG Implant Placement: CTG vs Flapless

The present study will evaluate the difference in terms of keratinazed mucosa (KM) in computer guided implant placement with immediate loading, comparing a flapless approach to flap surgery with connective tissue graft.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinica Odontoiatrica Giorgio Vogel

Milan, MI, 20142, Italy

Location status: Recruiting

Location contact

Eugenio Romeo, Prof.

CONTACT

[email protected]

0250319003

Eugenio Romeo, Prof.

SUB_INVESTIGATOR

Giulia Palandrani, Msc

SUB_INVESTIGATOR

Stefano Storelli, PHD

CONTACT

[email protected]

0250319003

Stefano Storelli, PHD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age 18+
  • Patients with partial edentulism in the posterior region (4-7) upper or lower for at least 3 months
  • Patient whose tomographic examination shows adequate bone volumes for computer guided placement of a standard diameter implant (> 3.5 mm) without the need for bone regeneration procedures
  • Patients who have accepted informed consent and participation in the study
  • Patients who do not have exclusion criteria

Eclusion Criteria

  • Patients who refuse to co-operate
  • Systemic conditions of exclusion:
  • Medical conditions requiring prolonged use of steroids
  • Severe hemophilia
  • In therapy with intravenous bisphosphonates
  • History of white blood cell dysfunction or deficiency
  • History of head and neck radiotherapy or chemotherapy
  • History of kidney failure
  • Pregnant or breastfeeding patient
  • History of uncontrolled endocrine disorders
  • Physical handicaps that hinder proper oral hygiene
  • Use of experimental devices or drugs within 30 days prior to implant placement surgery
  • Alcoholism or drug abuse
  • Smokers of> 10 cigarettes per day or the equivalent cigar or> 10 tobacco-based chewings per day
  • Conditions or circumstances that prevent the completion of participation in the study or interfere with the analysis of the study results

Local exclusion conditions:

  • Local inflammation, including untreated periodontitis
  • Patients with erosive lichen planus
  • History of local radiation therapy
  • Presence of bone lesions
  • Unhealed extraction sites
  • History of bone reconstruction and bone grafting techniques in the sites where the implants are to be inserted
  • Bruxism
  • Bleeding index> 30% and number of pockets> 5mm greater than 10

Treatment and study plan

connective tissue graft

Procedure

Implants will be placed with a flap and a connective tissue graft.

Flapless

Procedure

Implants will be placed with a flapless approach

Primary outcomes

  1. Widht of Keratinized mucosa

    Time frame: 2-4-8-12-24 weeks - 1-2-3-4-5 years

    variation of keratized mucosa from t0

Secondary outcomes

  1. implant survival

    Time frame: 1-2-3-4-5 years

    Implant in function

  2. marginal bone loss

    Time frame: 1-2-3-4-5 years

    variation of marginal bone loss over time

  3. Vas Scale

    Time frame: 2 weeks

    Prom: patient VAS scale for post-operative pain, from 0 to 10, where 10 is higher and 0 is minimum.

Other outcomes

  1. Time

    Time frame: day 1

    surgical time differences between the two groups

  2. prosthetic complications

    Time frame: 1-2-3-4-5 years

    number and type of prosthetic complications over time

Sponsors and collaborators

Lead sponsor

University of Milan

Other

Registry information

Official study title

Width of Keratinazed Mucosa in Immediately Loaded Posterior Implant Restorations Treated With Different Surgical Approaches: Randomized Clinical Study.

Important dates

Study start
2021
Primary completion
2023
Study completion
2028
First posted
Oct 12, 2021
Registry last updated
Dec 3, 2021

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.