Periodontal DiseasesNCT07054008
Microsurgery and Periodontal Healing
A study testing Microsurgical approach with Digital Microscope in people with Periodontal Diseases, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
Scientists do research to answer important questions which might help change or improve the way we do things in the future. The investigators know that using glasses with special attachments that provide magnification (dental loupes) for dental procedures results in better healing than not using magnification. Read more about this study
- Who is it for?
- Ages 18 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- Microsurgical approach with Digital Microscope
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2025to 31 Dec 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 to 18 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ability of subject to understand and the willingness to sign a written informed consent document.
- Males and females; Age 18 -89 years old
- Require surgical flap treatment of periodontal disease
- Either maxillary or mandibular arch
- ASA I or II
- Has consistent transportation for all clinical and study visits
Who cannot join
- Pregnancy, or those planning to become pregnant
- Diabetics with an HbA1c >7.1
- Not eligible for surgical periodontal therapy
- Require vertical or horizontal hard tissue augmentation
- Non-English speaking
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Angela A Palaiologou-Gallis, DDS., MS., 210-567-3567, palaiologoua@uthscsa.edu
About this study
Official title: The Effect of Microsurgical Approach to Periodontal Flap Healing: A Randomized Controlled Trial
Scientists do research to answer important questions which might help change or improve the way we do things in the future.
The investigators know that using glasses with special attachments that provide magnification (dental loupes) for dental procedures results in better healing than not using magnification. This study will test if using a microscope, that gives much higher magnification, can result in even better healing than using dental loupes.
Read the detailed description
A two-arm split mouth randomized controlled trial investigating the effect of using an experimental microsurgical approach with a digital microscope (Group 1) or standard of care surgical approach with dental loupes (Group 2) on post-operative wound healing of two standardized vertical releasing incisions. The split mouth design will ensure that each patient serves as their own control.
The hypothesis is that the wound closure technique in Group 1: Microsurgical approach with digital microscope will have improved periodontal flap vertical releasing incision wound healing as compared to the Group 2: Standard of Care surgical approach with dental loupes.
- Conditions
- Periodontal Diseases
- Being tested
- Microsurgical approach with Digital Microscope
- Keywords
- Surgical flap treatment
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microsurgical approach with Digital MicroscopeProcedure or surgery
Also called Microsurgery
The incision will be sutured with the use of a digital microscope (30 X) (Group 1). The microsurgical approach is a research only procedure that may add time to the total surgical time (< 6%).
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Microsurgical incision closure | Experimental | Microsurgical approach to wound closure using a digital microscope to enhance view Receives: Procedure: Microsurgical approach with Digital Microscope |
| Group 2: Dental loupes incision closure | No intervention | Standard of care surgical approach to wound closure using Dental Loupes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early wound healing index
Assessment of early soft tissue wound healing
Measured: One, two and three weeks
Secondary outcomes (1)
Difference in time between procedures
The time needed for suturing the incision with the digital microscope (Group 1) and with standard of care dental loupes (Group 2) will be documented immediately after placement of the last suture.
Measured: End of surgical procedure at last suture placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start31 Aug 2025
- Primary completion31 May 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- 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
- Sequential
- Model description
- A two-arm randomized controlled split-mouth trial. Subjects will be randomized only for the first (mesial) incision to Group 1 (microscope) or Group 2 (dental loupes). The second incision (distal) will receive the other treatment. Every patient will receive both treatments.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela Palaiologou-Gallis, DDS, MS, The University of Texas Health Science Center at San Antonio
- Investigators
- Angela Palaiologou-Gallis, DDS, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07054008
- Sponsor's protocol ID
- STUDY00001809
- Status last verified
- Nov 2025
- First submitted
- 27 Jun 2025
- Last updated
- 12 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The PI will ensure all mechanisms used to share data will include proper plans and safeguards for the protection of privacy, confidentiality, and security for data dissemination and reuse (e.g., all data will be thoroughly de-identified and will not be traceable to a specific study participant). Plans for archiving and long-term preservation of the data will be implemented as appropriate.
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Microsurgical Approach to Periodontal Flap Healing: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07054008
- Acronym / sponsor ID
- STUDY00001809
- Conditions
- Periodontal Diseases
- Keywords
- Surgical flap treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- 31 Aug 2025 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 Jul 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.
Scientists do research to answer important questions which might help change or improve the way we do things in the future.
The investigators know that using glasses with special attachments that provide magnification (dental loupes) for dental procedures results in better healing than not using magnification. This study will test if using a microscope, that gives much higher magnification, can result in even better healing than using dental loupes.
Detailed description
A two-arm split mouth randomized controlled trial investigating the effect of using an experimental microsurgical approach with a digital microscope (Group 1) or standard of care surgical approach with dental loupes (Group 2) on post-operative wound healing of two standardized vertical releasing incisions. The split mouth design will ensure that each patient serves as their own control.
The hypothesis is that the wound closure technique in Group 1: Microsurgical approach with digital microscope will have improved periodontal flap vertical releasing incision wound healing as compared to the Group 2: Standard of Care surgical approach with dental loupes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A two-arm randomized controlled split-mouth trial. Subjects will be randomized only for the first (mesial) incision to Group 1 (microscope) or Group 2 (dental loupes). The second incision (distal) will receive the other treatment. Every patient will receive both treatments.
| Arm | Type | Receives |
|---|---|---|
| Group 1: Microsurgical incision closure | Experimental | Procedure: Microsurgical approach with Digital MicroscopeMicrosurgical approach to wound closure using a digital microscope to enhance view |
| Group 2: Dental loupes incision closure | No intervention | –Standard of care surgical approach to wound closure using Dental Loupes. |
Who may qualify
- Ages
- 18 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Ability of subject to understand and the willingness to sign a written informed consent document.
- Males and females; Age 18 -89 years old
- Require surgical flap treatment of periodontal disease
- Either maxillary or mandibular arch
- ASA I or II
Key exclusion criteria (5 listed)
- Pregnancy, or those planning to become pregnant
- Diabetics with an HbA1c >7.1
- Not eligible for surgical periodontal therapy
- Require vertical or horizontal hard tissue augmentation
- Non-English speaking
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 |
|---|---|---|
| Microsurgical approach with Digital MicroscopeAlso: MicrosurgeryThe incision will be sutured with the use of a digital microscope (30 X) (Group 1). The microsurgical approach is a research only procedure that may add time to the total surgical time (< 6%). | Procedure or surgery | Group 1: Microsurgical incision closure |
Primary outcome
Early wound healing index
Time frame: One, two and three weeks
Assessment of early soft tissue wound healing
1 secondary outcome
Difference in time between procedures
Time frame: End of surgical procedure at last suture placement
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 12 Nov 2025.
- Individual participant dataSharing planned: Yes. The PI will ensure all mechanisms used to share data will include proper plans and safeguards for the protection of privacy, confidentiality, and security for data dissemination and reuse (e.g., all data will be thoroughly de-identified and will not be traceable to a specific study participant). Plans for archiving and long-term preservation of the data will be implemented as appropriate.
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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.
Angela Palaiologou-Gallis, DDS principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microsurgical approach with Digital Microscope in people with Periodontal Diseases, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 12 Nov 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 United States. 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 Angela Palaiologou-Gallis, DDS (210-450-3715, PalaiologouA@uthscsa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early wound healing index (time frame: One, two and three weeks). 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 12 Nov 2025.