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

NCT07452068 | Completed

• 1 other identifier: Dhanavath Prabhavathi
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Implant Stability

Outcome Measures

Primary Outcomes (1)

• Zygomatic implant stability

  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)

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

Secondary Outcomes (3)

• Associated sinus pathology

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

• Peri-Implant Soft Tissue Condition

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

• Prosthetic Offset

  Prosthetic Offset assessed at 3 and 6 months

Study Arms (2)

INTRASINUS

EXPERIMENTAL

PARAMETERS ASSESED: 1. IMPLANT STABILITY 2. SINUS PATHOLOGY 3. SOFT TISSUE CONDITIONING 4. PROSTHETIC OFFSET 18 SAMPLES INCLUDED

Procedure: ZYGOMATIC IMPLANT KIT

EXTRASINUS

ACTIVE COMPARATOR

PARAMETERS ASSESED: 1. IMPLANT STABILITY 2. SINUS PATHOLOGY 3. SOFT TISSUE CONDITIONING 4. PROSTHETIC OFFSET 18 SAMPLES INCLUDED

Procedure: ZYGOMATIC IMPLANT KIT

Interventions

ZYGOMATIC IMPLANT KIT PROCEDURE

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

EXTRASINUS; INTRASINUS

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

PGIDS

Rohtak, Haryana, 124001, India

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: March 5, 2026
• Study Start: March 31, 2023
• Primary Completion: April 25, 2024
• Study Completion: December 26, 2024
• Last Updated: March 5, 2026

Record last verified: 2026-02

Locations

IN (1)