Recession, GingivalNCT05342649
Effect of Two Methods of Soft Tissue Augmentation for Socket Closure on Soft Tissue Landmarks and Ridge Dimensions
A study testing P-CTG and CTG in people with Recession, Gingival, run by SVS Institute of Dental Sciences at 1 site in India.
Trial summary
To evaluate the effect of Connective Tissue Graft and Pediculated-Connective Tissue Graft for extraction socket closure on soft tissue landmarks and ridge dimensions. Read more about this study
- Who is it for?
- Ages 35 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Recession, Gingival
- What is being tested?
- P-CTG and CTG
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jan 2018to 20 Jun 2019
- 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 35 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Based on the Extraction Defect Sounding(EDS) Classification given by Caplanis et al,
- Systemically healthy subjects within the age group of 20-50years
- with extraction defect type 2 and type 3 were included in this study
Who cannot join
- Medically compromised patients
- Subjects who underwent radiotherapy or chemotherapy and
- Smokers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Effect of Two Methods of Soft Tissue Augmentation for Socket Closure on Soft Tissue Landmarks and Ridge Dimensions- Results From Software-based Analysis of Clinical Data"
To evaluate the effect of Connective Tissue Graft and Pediculated-Connective Tissue Graft for extraction socket closure on soft tissue landmarks and ridge dimensions.
Read the detailed description
45 subjects were randomized into two groups Experimental: Main treatment group P-CTG group Active Comparator: Control group CTG group.
- Conditions
- Recession, Gingival
- Being tested
- P-CTG, CTG
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P-CTGProcedure or surgery
Also called Experimental group
soft tissue closure of extraction sockets was done by pediculated connective tissue grafts (P-CTG)
CTGProcedure or surgery
Also called Control group
soft tissue closure of extraction sockets was done by connective tissue grafts (CTG)
| Study group | Role | What they receive |
|---|---|---|
| Main treatment group | Experimental | soft tissue closure of extraction sockets was done by pediculated connective tissue grafts (P-CTG) Receives: Procedure: P-CTG |
| Control group | Active comparator | soft tissue closure of extraction sockets was done by connective tissue grafts (CTG) Receives: Procedure: CTG |
What is being measured
The primary outcome is the main question the study is designed to answer.
BL Gain
The displacement from the baseline to 6-months in BL dimensions was calculated and was described as BL gain.
Measured: Baseline to 6 months
Total displacement (TD)
The total displacement (TD) from the baseline to 6-months in MD dimensions was calculated and was described as TD gain.
Measured: Baseline to 6 months
Angle of Displacement (AOD)
The Angle of Displacement (AOD)) from the baseline to 6-months in MD dimensions was calculated and was described as AOD Change.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start1 Jan 2018
- Primary completion1 May 2019
- Study completion20 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recession, GingivalStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- SVS Institute of Dental Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr R Viswa Chandra, SVS Institute of Dental Sciences
- Investigators
- Bhagyasree Medisetty, MDS, Principal investigator, SVS Institute of Dental Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05342649
- Sponsor's protocol ID
- SVSIDS/PERIO/1/2017
- Status last verified
- Apr 2022
- First submitted
- 8 Apr 2022
- Last updated
- 22 Apr 2022
- Results posted
- No
- 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 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Effect of Two Methods of Soft Tissue Augmentation for Socket Closure on Soft Tissue Landmarks and Ridge Dimensions- Results From Software-based Analysis of Clinical Data"
- ClinicalTrials.gov ID
- NCT05342649
- Acronym / sponsor ID
- SVSIDS/PERIO/1/2017
- Conditions
- Recession, Gingival
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- SVS Institute of Dental SciencesUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 20 Jun 2019 (actual)
- First posted
- 22 Apr 2022 (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.
To evaluate the effect of Connective Tissue Graft and Pediculated-Connective Tissue Graft for extraction socket closure on soft tissue landmarks and ridge dimensions.
Detailed description
45 subjects were randomized into two groups Experimental: Main treatment group P-CTG group Active Comparator: Control group CTG group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Main treatment group | Experimental | Procedure: P-CTGsoft tissue closure of extraction sockets was done by pediculated connective tissue grafts (P-CTG) |
| Control group | Active comparator | Procedure: CTGsoft tissue closure of extraction sockets was done by connective tissue grafts (CTG) |
Who may qualify
- Ages
- 35 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Based on the Extraction Defect Sounding(EDS) Classification given by Caplanis et al,
Key exclusion criteria (3 listed)
- Medically compromised patients
- Subjects who underwent radiotherapy or chemotherapy and
- Smokers
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 |
|---|---|---|
| P-CTGAlso: Experimental groupsoft tissue closure of extraction sockets was done by pediculated connective tissue grafts (P-CTG) | Procedure or surgery | Main treatment group |
| CTGAlso: Control groupsoft tissue closure of extraction sockets was done by connective tissue grafts (CTG) | Procedure or surgery | Control group |
Primary outcome
BL Gain
Time frame: Baseline to 6 months
The displacement from the baseline to 6-months in BL dimensions was calculated and was described as BL gain.
Total displacement (TD)
Time frame: Baseline to 6 months
The total displacement (TD) from the baseline to 6-months in MD dimensions was calculated and was described as TD gain.
Angle of Displacement (AOD)
Time frame: Baseline to 6 months
The Angle of Displacement (AOD)) from the baseline to 6-months in MD dimensions was calculated and was described as AOD Change.
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 22 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Bhagyasree Medisetty, MDS principal investigator
SVS Institute of Dental Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing P-CTG and CTG in people with Recession, Gingival, run by SVS Institute of Dental Sciences 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 3 inclusion and 3 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 22 Apr 2022. 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?
BL Gain (time frame: Baseline to 6 months). The study lists 3 primary outcomes in all. 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 22 Apr 2022.