Implant StabilityNCT07452068
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
A study testing ZYGOMATIC IMPLANT KIT in people with Implant Stability, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Implant Stability
- What is being tested?
- ZYGOMATIC IMPLANT KIT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteIndia
- Study dates
- 31 Mar 2023to 26 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this 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.
- Conditions
- Implant Stability
- Being tested
- ZYGOMATIC IMPLANT KIT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZYGOMATIC IMPLANT KITProcedure or surgery
CRESTAL INCISION FROM TUBEROSITY TO TUBEROSITY AND REFLECT THE FLAP . OSTEOTOMY DONE FROM MOLAR TO ZYGOMATIC BONE.IMPLANT PLACEMENT DONE
| Study group | Role | What they receive |
|---|---|---|
| INTRASINUS | Experimental | PARAMETERS ASSESED:
1. IMPLANT STABILITY
2. SINUS PATHOLOGY
3. SOFT TISSUE CONDITIONING
4. PROSTHETIC OFFSET 18 SAMPLES INCLUDED Receives: 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 Receives: Procedure: ZYGOMATIC IMPLANT KIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Implant stability was evaluated individually after 3 and 6 months of implant placement and prosthetic rehabilitation
Secondary outcomes (3)
Associated sinus pathology
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
Measured: 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 after implant placement and prosthetic replacement, where the exposed implant surface was measured from the implant head to the soft tissue recession area.
Measured: Soft tissue around the zygomatic implant was assessed at 3 and 6 months
Prosthetic Offset
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.
- 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
Measured: Prosthetic Offset assessed at 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start31 Mar 2023
- Primary completion25 Apr 2024
- Study completion26 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant StabilityStudies of the same condition, open and under way.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07452068
- Sponsor's protocol ID
- Dhanavath Prabhavathi
- Status last verified
- Feb 2026
- First submitted
- 4 Feb 2025
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07452068
- Acronym / sponsor ID
- Dhanavath Prabhavathi
- Conditions
- Implant Stability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 31 Mar 2023 (actual)
- Primary completion
- 25 Apr 2024 (actual)
- Study completion
- 26 Dec 2024 (actual)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INTRASINUS | Experimental | Procedure: ZYGOMATIC IMPLANT KITPARAMETERS ASSESED: 1. IMPLANT STABILITY 2. SINUS PATHOLOGY 3. SOFT TISSUE CONDITIONING 4. PROSTHETIC OFFSET 18 SAMPLES INCLUDED |
| EXTRASINUS | Active comparator | Procedure: ZYGOMATIC IMPLANT KITPARAMETERS ASSESED: 1. IMPLANT STABILITY 2. SINUS PATHOLOGY 3. SOFT TISSUE CONDITIONING 4. PROSTHETIC OFFSET 18 SAMPLES INCLUDED |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZYGOMATIC IMPLANT KITCRESTAL INCISION FROM TUBEROSITY TO TUBEROSITY AND REFLECT THE FLAP . OSTEOTOMY DONE FROM MOLAR TO ZYGOMATIC BONE.IMPLANT PLACEMENT DONE | Procedure or surgery | EXTRASINUS, INTRASINUS |
Primary outcome
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)
3 secondary outcomes
Associated sinus pathology
Time frame: Associated sinus pathologywas assessed at 3 and 6 months after implant placement
Peri-Implant Soft Tissue Condition
Time frame: Soft tissue around the zygomatic implant was assessed at 3 and 6 months
Prosthetic Offset
Time frame: Prosthetic Offset assessed at 3 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ZYGOMATIC IMPLANT KIT in people with Implant Stability, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Zygomatic implant stability (time frame: Implant stability was evaluated individually after 3 and 6 months of implant placement and prosthetic rehabilitation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.