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OpenTrials
Completed

NCT Number: NCT06528587

Rehabilitation of Single Aesthetic Areas Using Narrow Diameter Implants

The scientific literature does not provide scientific evidence on how to manage patients suffering from monoedentulism with ridges having a reduced bone thickness or a reduced mesio-distal space. Narrow diameter implants could be a solution to rehabilitate patients suffering from these clinical conditions while avoiding longer, more complex and sometimes even multidisciplinary therapies. However, there is a lack of clinical studies analyzing the outcomes of rehabilitation with narrow diameter implants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, Roma, 00168, Italy

About this study

Dental implants are considered a predictable rehabilitation option in the event of tooth extraction or missing tooth. In some cases, the inevitable resorption of the alveolar ridge after tooth extraction can make the insertion of dental implants difficult or even impossible without the use of more advanced bone regeneration procedures. Narrow diameter implants represent an alternative treatment option in areas with limited ridge width. Narrow alveolar ridges and limited interdental or inter-implant spaces continue to pose a challenge to the clinician. In the case of a narrow ridge, two options are available: the first option is to insert a standard diameter implant following bone augmentation procedures; the second option is to use an implant with a narrow diameter. Regarding the mesio-distal gap, an adequate distance between teeth and implants is necessary to reduce subsequent bone resorption and recession of the papillae. Difficult clinical situations with limited mesio-distal space or reduced ridge width can be overcome by using narrow diameter implants. Correct three-dimensional implant positioning is the key factor to obtain, in addition to good integration, favorable prosthetic results and a good long-term aesthetic result. To optimize the insertion of the implants, reducing the intrinsic imprecision of the conventional free-hand technique, computer-guided static surgery protocols can be used to plan the angulation, position and depth of the implant with a digital software. Narrow diameter implants therefore have their own indication for the replacement of lateral incisors of the maxilla and for the incisors of the mandible.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients who have undergone implant surgery to perform implant rehabilitation of single edentulism in the anterior region to insert a reduced diameter implant;
  • ASA I and ASA II patients;
  • Age > 18yr;
  • Non-smokers or smokers ≤ 5 cig/day;
  • Achievement of FMPS and FMBS ≤ 15%;
  • Signing of the written informed consent to participate in the study.

Exclusion criteria

  • Severe general medical pathologies;
  • Immunodeficiency states;
  • Radiotherapy in the head and neck region;
  • Uncontrolled diabetes or hypertension;
  • Smokers >5 cigs/day;
  • Impossibility to carry out homogeneous and continuous follow-up;
  • Documented allergy to the biomaterials used;
  • Pregnancy or breastfeeding;
  • Inability to provide written informed consent.

Treatment and study plan

narrow diameter implant

Procedure

Rehabilitation of single edentulism in the anterior region with narrow diameter implants and computer guided surgery.

Primary outcomes

  1. peri-implant marginal bone loss in millimeters

    Time frame: 12 months from implant placement

    evaluation of the peri-implant marginal bone loss in millimeters

Secondary outcomes

  1. soft tissue evaluation in millimeters

    Time frame: 12 months from implant placement

    evaluation of marginal soft tissues levels in millimeters

  2. biological complication rate in percentage

    Time frame: 12 months from implant placement

    evaluation of biological complications in percentage

  3. esthetics

    Time frame: 12 months from implant placement

    evaluation of the esthetics using the PES score

  4. mechanical complication rate in percentage

    Time frame: 12 months from implant placement

    evaluation of mechanical complications in percentage

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Rehabilitation of Single Aesthetic Areas Using Narrow Diameter Implants With Computer Guided Implant Insertion: a Prospective Study

Acronym: IDR

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 30, 2024
Registry last updated
Jan 8, 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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