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NCT Number: NCT06526351

Immediate vs Conventional Loading for Early Implant Placement

The goal of this study is to assess clinical, radiological and patient centred outcomes of immediate and conventional implant loading protocols, and to compare clinical outcomes of these two different loading protocols (immediate and conventional) in combination with early implant placement of single implants in the esthetic zone of maxilla.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Patients with a single failing tooth in the esthetic zone of maxilla (second premolar to second premolar), and in need for implant replacement will be recruited.

During the first appointment, medical history and clinical and radiological evaluations (OPG) will be recorded to verify the eligibility of each subject. If the sufficient bone is present apical to the failing tooth, intraoral scan of the upper jaw will be obtained prior to tooth extraction. Six to eight weeks following tooth extraction CBCT scan will be obtained together with digital impression. The implant positions will be planned according to the bone anatomy and future prosthetic reconstruction. Two groups of treatment protocols will be randomized as following:

Group 1: Early implant placement + immediate provisionalisation; Group 2: Early implant placement + conventional loading.

Implant surgery will be performed by two experienced surgeons. Full thickness triangular flap will be elevated, and fully guided implant placement will be completed. Under-preparation of implant bed in the soft bone will be utilized to obtain adequate primary stability. During the surgery, primary implant stability will be monitored by the means of insertion torque (IT) and resonance frequency analysis (RFA) Contour augmentation will be done for all patients from both groups by means of locally collected autogenous bone chips and deproteinized bovine bone particles, covered by a collagen membrane. Depending on the group, healing cap or healing abutment will be selected, and primary wound closure will be achieved.

Prosthetic rehabilitation:

All impressions will be taken digitally using intraoral scanner and appropriate implant scanbody.

Titanium temporary abutments will be used for provisional restorations, and titanium base abutments for the definitive restoration. Provisional restorations will be made of polymethyl methacrylate (PMMA) (Telio®CAD, Ivoclar Vivadent, Schaan, Lichtenstein) in a digital way. Digital scanning for final restorations and virtual design will be repeated in the same manner. Full ceramic screw-retained crown will be fabricated in a digital way and delivered to the patients.

Group 1:

Immediate screw-retained provisional restoration made of poly methyl methacrylate (PMMA) will be delivered within the first 7 days after surgery. Three months later, final screw-retained full ceramic crown will be fabricated and delivered.

Group 2:

Three months after the surgery, implant will be exposed and provisional screw-retained PMMA restoration delivered. Three months later final screw-retained ceramic crown will be fabricated.

Implant stability will be monitored through RFA. ISQ will be measured in both groups:

  • At the day of the implant placement
  • At the day of the provisional restoration placement
  • At the day of the definitive restoration placement

CBCT scan with a small field of view will be taken prior to implant placement, immediately after implant placement, and 1 year after implant placement. Post-op CBCT scans will be used for measurement of the facial bone wall thickness. Marginal bone level will be monitored using periapical radiographs taken with paralleling technique, using custom silicone holder fabricated for each patient. X-rays will be taken on the day of the provisional restoration placement, final restoration placement, and one year after final restoration.

Esthetic outcome for the peri-implant mucosa will be assessed from the photographs taken at the definitive restoration delivery and 1 year follow-up visit, using pink esthetic score (PES). Patient satisfaction regarding function and aesthetics (mucosa, crown and overall) would be assessed using visual analogue scale (VAS). Quality of life would be examined by OHIP-14 questionnaire. These Patient Reported Outcome Measures (VAS and OHIP-14) would be recorded at 3 time points: before implant placement (baseline), 1 month after definitive crown delivery and after 1 year of function.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Single failing tooth in the esthetic zone of maxilla (second premolar to second premolar)
  • Patients older than 18 years
  • Healthy patients ASA I and II
  • Non-smokers/Light smokers (<10 cigarettes per day)
  • Adequate bone volume apical and palatal to the failing tooth to allow for sufficient primary - implant stability of regular diameter implant

Exclusion criteria

  • Implants adjacent to the failing teeth
  • Active periodontal infection
  • Severe bruxism
  • Systemic or local conditions that contraindicates dental implant surgery - Heavy smokers (>10 cigarettes per day)

Treatment and study plan

Early implant placement with immediate provisional restoration

Device

Implants placed following early implant placement protocol with soft tissue healing (6-8 weeks after tooth extraction). GBR procedure performed together with implant placement. Immediate provisional restoration will be delivered.

Early implant placement with delayed loading

Device

Implants placed following early implant placement protocol with soft tissue healing (6-8 weeks after tooth extraction). GBR procedure performed together with implant placement. Delayed loading protocol followed.

Primary outcomes

  1. Marginal bone level changes

    Time frame: 1 year

    Marginal bone level will be monitored using periapical radiographs taken with paralleling technique, using custom silicone holder fabricated for each patient. X-rays will be taken on the day of the provisional restoration placement, final restoration placement, and one year after final restoration.

  2. Pink esthetic score

    Time frame: 1 year

    Esthetic outcome for the peri-implant mucosa will be assessed from the photographs taken at the definitive restoration delivery and 1 year follow-up visit. Seven variables (mesial papilla, distal papilla, soft-tissue level, soft- tissue contour, alveolar process deficiency, soft-tissue color and texture) are assessed with a score 0, 1 or 2. Highest possible score is 14.

Secondary outcomes

  1. Implant survival

    Time frame: 1 year

    Implant survival is assessed at provisional restoration delivery, final restoration delivery and at 1 year follow up

  2. Facial bone wall width

    Time frame: 1 year

    Facial bone wall width is measured in mm at CBCT scans obtained immediately after implant placement and 1 year after final restoration delivery

  3. Alveolar ridge volume

    Time frame: 1 year

    Alveolar ridge volume changes will be measured in mm in the image analysis software , by superimposing digital models (STL files) obtained prior to tooth extraction, prior to implant placement, at final restoration delivery, and 1year after final restoration delivery.

  4. Patient satisfaction

    Time frame: 1 year

    Patient satisfaction regarding function and aesthetics (mucosa, crown and overall) would be assessed using visual analogue scale (VAS). It is recorded in 4 time points: before tooth extraction, before implant placement, 1 month after definitive crown delivery and after 1 year of function.

  5. Impact of oral health on patient's quality of life

    Time frame: 1 year

    Oral Health Impact Profile (OHIP-14) questionnare will be used. Patients will fill a questionnare of 14 questions with responses made on a 5-point scale, coded 0 (never), 1 (hardly ever), 2 (occasionally), 3 (fairly often), and 4 (very often). Scores can range from 0 to 56, with higher OHIP-14 scores indicating worse and lower scores indicating better oral health related quality of life. It is recorded in 4 time points: before tooth extraction, before implant placement, 1 month after definitive crown delivery and after 1 year of function.

Study contacts

Contact information is provided by the study sponsor or research team.

Aleksa Markovic, Professor

CONTACT

[email protected]

+381116964380

Marko Magic, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Belgrade

Other

Collaborators

  • ITI International Team for Implantology, Switzerland

Registry information

Official study title

Immediate Vs. Conventional Loading for Early Implant Placement in the Esthetic Zone of Maxilla: Randomized Controlled Clinical Trial

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 29, 2024
Registry last updated
Jul 29, 2024

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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