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Completed

NCT Number: NCT07452068

Comparison of Intrasinus and Extrasinus Approach for the Placement of Zygomatic Implants in Severely Resorbed Edentulous Maxillary Arch Using Zygomatic Success Code - An In-Vivo Study

Various approach has outlined in the literature but no clinical studies that have compared the intrasinus and extrasinus approach for the placement of zygomatic implants using zygomatic success code.

The present study is planned to compare the intrasinus and extrasinus approach for the placement of zygomatic implant in severely resorbed edentulous maxillary arch using zygomatic success code.

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Key information

Conditions

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PGIDS

Rohtak, Haryana, 124001, India

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Completely edentulous maxilla.
  • Both gender without any systemic disease.
  • Patients with Misch-Type III edentulous maxillary arch and with Seibert's Class III ridge.
  • ZAGA-4 patients (pronounced buccal concavities of the maxilla).

Exclusion criteria

  • Any systemic illness/medications
  • Radiation therapy to the head and neck region 12 months prior to the proposed therapy.
  • Smoking
  • Pregnant and lactating women
  • Drug allergy
  • Bisphosphonates medication
  • Alcohol/ drug addiction
  • Maxillary sinusitis

Treatment and study plan

ZYGOMATIC IMPLANT KIT

Procedure

CRESTAL INCISION FROM TUBEROSITY TO TUBEROSITY AND REFLECT THE FLAP . OSTEOTOMY DONE FROM MOLAR TO ZYGOMATIC BONE.IMPLANT PLACEMENT DONE

Primary outcomes

  1. Zygomatic implant stability

    Time frame: Implant stability was evaluated individually after 3 and 6 months of implant placement and prosthetic rehabilitation

    When extra-sinus and intra-sinus placed implants are tested individually, slight mobility should be detected with no other associated pathological signs. Instrument used for checking the implant stability is periotest.

    Mobility of the implant comes from the elastic modulus of the anchoring zygomatic bone when they are bent by a remotely applied force. On the other hand, the movement must not be rotational, and it will disappear when implants are splinted together. A rotational movement should be considered as a sign of implant failure. Grade I- no mobility, no pain Grade II-light clinical mobility, no pain Grade III-clear clinical mobility, no pain (no evidence of disintegration of the apical part of the implant or rotation Grade IV- clear clinical mobility, rotation and pain evidence of disintegration of apical part of the implant)

Secondary outcomes

  1. Associated sinus pathology

    Time frame: Associated sinus pathologywas assessed at 3 and 6 months after implant placement

    Frequently associated complications such as rhinitis and sinusitis were assessed by two scoring systems: Lund-Mackay staging and the Lanza and Kennedy score.

    Lund-Mackay stating and Lanza and Kennedy score

    This system scored six sinus regions: anterior ethmoid, posterior ethmoid, maxillary sinus, frontal sinus, sphenoid sinus, and osteomeatal complex for sinus pathology. The score 0 represented no abnormality; 1 represented partial opacification; and 2 represented total opacification. For the osteomeatal complex, the score was either 0 or 2. This scoring was done for pre-operative and post-operative evaluation.

    Lanza-Kennedy - Rhinosinusal Clinical Symptoms

    It is patient-related questionnaire to identify the rhinosinusal clinical symptoms. Each symptom

    question is answered by "yes" or "no". The diagnosis of sinusitis requires a "yes" answer in two or more major criteria, one major and two or more minor criteria, or purulence on nasal examination

  2. Peri-Implant Soft Tissue Condition

    Time frame: Soft tissue around the zygomatic implant was assessed at 3 and 6 months

    Soft tissue around the zygomatic implant was assessed at 3 and 6 months after implant placement and prosthetic replacement, where the exposed implant surface was measured from the implant head to the soft tissue recession area.

  3. Prosthetic Offset

    Time frame: Prosthetic Offset assessed at 3 and 6 months

    Prosthetic success depends on the anatomic measurements to assess the implant position of the head of the zygomatic implant.

    Four anatomical measurements will be performed to assess the following:

    • Perpendicular distance between the tangent to the floor of the nose and sinus floor at the entrance of the zygomatic implant level.
    • Perpendicular distance between the tangent to the floor of the nose and the crest of the alveolar ridge at the entrance of the zygoma implant level.

    i. The height of the alveolar ridge at the location of the head of the zygomatic implant (measurement 2 minus 1)

    • Distance between the midline of the palate and the center of the zygomatic implant head.
    • Distance between the midline of the palate and the center of the alveolar ridge.

    ii. The position of the head of the zygomatic implants with regard to the center of the crest of the alveolar ridge in the horizontal axial dimension (measurement 4 minus 3).

    A positive value on this implant head position

Sponsors and collaborators

Lead sponsor

Postgraduate Institute of Dental Sciences Rohtak

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 5, 2026
Registry last updated
Mar 5, 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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