Dental Implant StabilityNCT06989684
Implant Stability Changes Using Underdrilling Versus Osseodensification Protocols for Posterior Dental Implants
A study testing Osseodensification and Underdrilling in people with Dental Implant Stability, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
This clinical trial aims to compare two drilling protocols Underdrilling and Osseodensification for placing dental implants in patients with low bone density. The purpose is to compare which technique provides better primary and secondary implant stability in the posterior regions of the jaw with low bone density. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implant Stability
- What is being tested?
- Osseodensification and Underdrilling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteIndia
- Study dates
- Sep 2025to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient partially edentulous ridge after extraction of more than 6 months and with low bone density.
- Systemically healthy patients ≥18 years of age.
Who cannot join
- Smokers.
- Pregnant or lactating females.
- Uncontrolled systemic disease like diabetes, hypertension, hormonal therapy and hematologic diseases.
- History of Maxillary sinus pathology.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Implant Stability And Changes In Ridge Width Using Underdrilling Versus Osseodensification Protocols For Posterior Dental Implant- A Randomized Clinical Trial
This clinical trial aims to compare two drilling protocols Underdrilling and Osseodensification for placing dental implants in patients with low bone density. The purpose is to compare which technique provides better primary and secondary implant stability in the posterior regions of the jaw with low bone density. The hypothesis is that there is no significant difference in implant stability between the two protocols.
Read the detailed description
Achieving sufficient primary stability becomes difficult in areas with low bone density. One technique commonly used is Underdrilling protocol.With the Underdrilling technique, the final osteotomy is smaller than the diameter of the implant to be placed.A relatively new Osseodensification protocol, introduced by Huwais in 2013, employs specially designed bur that smoothly compact the bone as they expand an osteotomy. This may prove to be particularly helpful in cases with low bone quality.This clinical trial aims to compare the implant stability using these drilling protocols
- Conditions
- Dental Implant Stability
- Being tested
- Osseodensification, Underdrilling
- Keywords
- secondary implant stability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsseodensificationProcedure or surgery
Osseodensification uses specially designed burs to densify osteotomy site
UnderdrillingProcedure or surgery
In underdrilling the osteotomy is smaller than implant diameter to be placed
| Study group | Role | What they receive |
|---|---|---|
| Osseodensification | Active comparator | Osseodensification uses special densa burs for osteotomy site compaction Receives: Procedure: Osseodensification |
| Underilling | Active comparator | In Underdrilling the osteotomy is smaller than implant diameter to be placed Receives: Procedure: Underdrilling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant stability
It compares Primary stability and Secondary stability after implant placement. Primary stability is recorded by insertion torque values from manual torque wrench. Secondary stability is recorded by resonance frequency analysis.
Measured: 12-18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study startSep 2025 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr.Ritika Arora, MDS, Principal investigator, PGIDS,Rohtak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06989684
- Sponsor's protocol ID
- CHAINSHILPA-PERIO
- Status last verified
- May 2025
- First submitted
- 9 May 2025
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implant Stability And Changes In Ridge Width Using Underdrilling Versus Osseodensification Protocols For Posterior Dental Implant- A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06989684
- Acronym / sponsor ID
- CHAINSHILPA-PERIO
- Conditions
- Dental Implant Stability
- Keywords
- secondary implant stability
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 25 May 2025 (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.
This clinical trial aims to compare two drilling protocols Underdrilling and Osseodensification for placing dental implants in patients with low bone density. The purpose is to compare which technique provides better primary and secondary implant stability in the posterior regions of the jaw with low bone density. The hypothesis is that there is no significant difference in implant stability between the two protocols.
Detailed description
Achieving sufficient primary stability becomes difficult in areas with low bone density. One technique commonly used is Underdrilling protocol.With the Underdrilling technique, the final osteotomy is smaller than the diameter of the implant to be placed.A relatively new Osseodensification protocol, introduced by Huwais in 2013, employs specially designed bur that smoothly compact the bone as they expand an osteotomy. This may prove to be particularly helpful in cases with low bone quality.This clinical trial aims to compare the implant stability using these drilling protocols
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osseodensification | Active comparator | Procedure: OsseodensificationOsseodensification uses special densa burs for osteotomy site compaction |
| Underilling | Active comparator | Procedure: UnderdrillingIn Underdrilling the osteotomy is smaller than implant diameter to be placed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient partially edentulous ridge after extraction of more than 6 months and with low bone density.
- Systemically healthy patients ≥18 years of age.
Key exclusion criteria (4 listed)
- Smokers.
- Pregnant or lactating females.
- Uncontrolled systemic disease like diabetes, hypertension, hormonal therapy and hematologic diseases.
- History of Maxillary sinus pathology.
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 |
|---|---|---|
| OsseodensificationOsseodensification uses specially designed burs to densify osteotomy site | Procedure or surgery | Osseodensification |
| UnderdrillingIn underdrilling the osteotomy is smaller than implant diameter to be placed | Procedure or surgery | Underilling |
Primary outcome
Implant stability
Time frame: 12-18 months
It compares Primary stability and Secondary stability after implant placement. Primary stability is recorded by insertion torque values from manual torque wrench. Secondary stability is recorded by resonance frequency analysis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Individual participant dataSharing planned: No
Related trials for Dental Implant Stability
Recruiting
Digital Eye®-Assisted Bone Density Classification and Primary Dental Implant Stability.
Bone Mineral Density, Primary Implant Stability
RecruitingObservational study
Movement of Dental Implants During Osseointegration
Dental Implants, Osseointegration
RecruitingPhase 2/3
Lactoferrin Nanohydrogel for Soft And Hard Tissue Healing and Implant Stability in Immediate Implant Placement
Dental Implant, Wound Healing
Active, not recruitingObservational study
Long-Term Stability of Soft and Hard Tissues After Guided Bone Regeneration in the Maxillary Anterior Region
Alveolar Bone Deficiency
Recruiting
Melatonin Effect on Immediate Dental Implants in the Posterior Mandible
Dental Implant, Immediate Dental Implant Placement
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.
Dr.Ritika Arora, MDS principal investigator
PGIDS,Rohtak
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osseodensification and Underdrilling in people with Dental 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 2 inclusion and 4 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: opening soon, as of the sponsor's last update on 25 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chain Shilpa, MDS (+91 9814272797, www.dalbirsingh047@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant stability (time frame: 12-18 months). 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 25 May 2025.