Gingival AtrophyNCT06238427
Soft Tissue Augmentation Around Dental Implant
An observational study of Gingival Atrophy, run by Mansoura University at 1 site in Egypt.
Trial summary
Patients were randomly distributed into two groups (G1 and G2), all patients were treated by a submerged dental implant protocol and free gingival graft (FGG) harvested from the palate as follows: Group 1 (G1), received the FGG two months before implant placement. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Atrophy
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Jul 2019to 15 Jun 2020
- Phase
- Observational
- 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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Twenty patients (12 female / 8 male) seeking dental implant placement due to missing teeth and deficient keratinized mucosa width were enrolled in this observational study. The study population was selected from patients attending the clinic of the Periodontology Department of Oral Medicine and Periodontology at Mansoura University. Recruitment occurred from July 2019 to June 2022..
Who may be able to join
- Age: 21 years or older
- Systemic Condition: Healthy
- Keratinized Mucosa Width: Less than 2mm at the intended implant site
- Bucco-lingual Bone Width: At least 5.5 mm in a single edentulous space
- Mesio-distal Distance: At least 7 mm between adjacent teeth in a single edentulous space
- Minimal Bone Height: Not less than 10 mm
Show all 9Show fewer
- Residual Alveolar Ridge: Healthy and well-formed, covered with firm mucosa
- Periodontal Health: Absence of signs of periodontal bone loss or significant soft tissue .loss in teeth adjacent to the implant site
- Inter-arch Space: Adequate, exceeding 7 mm
Who cannot join
- Cooperation: Uncooperative patients
- Pregnancy: Individuals with known pregnancies
- Parafunctional Habits: Abnormal parafunctional habits such as bruxism and clenching
- Systemic Illnesses: Patients with systemic illnesses that could disrupt healing
- Medication: Individuals receiving systemic corticosteroids or other drugs impacting .osseointegration or post-operative healing
- Smoking: Smokers consuming more than 10 cigarettes per day
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Timing of Soft Tissue Augmentation to Increase Width of Keratinized Mucosa Around Dental Implant
Patients were randomly distributed into two groups (G1 and G2), all patients were treated by a submerged dental implant protocol and free gingival graft (FGG) harvested from the palate as follows:
- Group 1 (G1), received the FGG two months before implant placement.
- Group 2 (G2), received the FGG at the time of second-stage surgery (i.e. at the time of healing abutment placement).
All periodontal and radiographic assessments were done by the same operator who was neither involved in the evaluation nor the distribution process. The operator did all the evaluation steps and was completely blinded to the treatment protocol.
Read the detailed description
In this investigation, a randomized clinical trial was employed. The patient's randomization was completed by one of the department's senior residents, who was not involved in the trial and was unaware of any relevant treatment plan. A computer-generated randomization list used a randomization table to perform the randomization (SPSS v23.0). Patients were randomly distributed into two groups (G1 and G2), all patients were treated by a submerged dental implant protocol and FGG harvested from the palate. All patients received a thorough description of all procedures involved in the study. Signing a written consent was mandatory for being enrolled in the study. Complete medical and dental histories were recorded for all patients and complete clinical intraoral and extraoral examinations were done for all patients.
Selected patients were questioned about the cause and time of extractions, whether extractions were because of periodontal disease, dental decay or other causes. Previous experiences with dental procedures were also discussed. Intraoral photographs were taken to record the existing condition of teeth and mucosa before implant placement.
- Conditions
- Gingival Atrophy
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Group 1 participants underwent free gingival graft placement two months before implant placement. | |
| Group2 | Group 2 in which the participants underwent the placement of the free gingival graft during the second stage of surgery, specifically at the time of healing abutment placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Keratinized Mucosa Width (KMW)
Measurement Method: The assessment of KMW involved measuring from the alveolar ridge zenith to the muco-gingival junction (MGJ) using a calibrated periodontal probe.
Unit of Measure: Millimeters (mm)
Measured: Baseline, 1 month, 3 months, 6 months, and 9 months
Soft Tissue Thickness (STT)
Measurement Method: STT was determined 1.5 mm apical to the soft tissue margin (STM) using a short anesthesia needle or endodontic micro-opener with a silicon stopper.
Unit of Measure: Millimeters (mm) Measurement Procedure: The needle was inserted perpendicular to the mucosal surface, through the soft tissues with light pressure until a hard surface was felt. The silicon stopper was placed in tight contact with the soft tissue surface, and the penetrated part was measured on an endodontic ruler. Measurements were rounded to the nearest half of a millimeter.
Measured: Baseline, 1 month, 3 months, 6 months, and 9 months
Graft Shrinkage
The decrease in the size of the graft at each follow-up time was compared to the baseline. size. It was presented in percentage
Measured: 1 month, 3 months, 6 months, and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start13 Jul 2019
- Primary completion15 Jun 2020
- Study completion15 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival AtrophyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samah Elmeadawy, Ph.D, Study director, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06238427
- Sponsor's protocol ID
- A11100221
- Status last verified
- Dec 2023
- First submitted
- 28 Dec 2023
- Last updated
- 2 Feb 2024
- 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 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Timing of Soft Tissue Augmentation to Increase Width of Keratinized Mucosa Around Dental Implant
- ClinicalTrials.gov ID
- NCT06238427
- Acronym / sponsor ID
- A11100221
- Conditions
- Gingival Atrophy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 13 Jul 2019 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 15 Jun 2020 (actual)
- First posted
- 2 Feb 2024 (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.
Patients were randomly distributed into two groups (G1 and G2), all patients were treated by a submerged dental implant protocol and free gingival graft (FGG) harvested from the palate as follows:
- Group 1 (G1), received the FGG two months before implant placement.
- Group 2 (G2), received the FGG at the time of second-stage surgery (i.e. at the time of healing abutment placement).
All periodontal and radiographic assessments were done by the same operator who was neither involved in the evaluation nor the distribution process. The operator did all the evaluation steps and was completely blinded to the treatment protocol.
Detailed description
In this investigation, a randomized clinical trial was employed. The patient's randomization was completed by one of the department's senior residents, who was not involved in the trial and was unaware of any relevant treatment plan. A computer-generated randomization list used a randomization table to perform the randomization (SPSS v23.0). Patients were randomly distributed into two groups (G1 and G2), all patients were treated by a submerged dental implant protocol and FGG harvested from the palate. All patients received a thorough description of all procedures involved in the study. Signing a written consent was mandatory for being enrolled in the study. Complete medical and dental histories were recorded for all patients and complete clinical intraoral and extraoral examinations were done for all patients.
Selected patients were questioned about the cause and time of extractions, whether extractions were because of periodontal disease, dental decay or other causes. Previous experiences with dental procedures were also discussed. Intraoral photographs were taken to record the existing condition of teeth and mucosa before implant placement.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Group 1 participants underwent free gingival graft placement two months before implant placement. |
| Group2 | – | –Group 2 in which the participants underwent the placement of the free gingival graft during the second stage of surgery, specifically at the time of healing abutment placement |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Twenty patients (12 female / 8 male) seeking dental implant placement due to missing teeth and deficient keratinized mucosa width were enrolled in this observational study. The study population was selected from patients attending the clinic of the Periodontology Department of Oral Medicine and Periodontology at Mansoura University. Recruitment occurred from July 2019 to June 2022..
Key inclusion criteria (9 listed)
- Age: 21 years or older
- Systemic Condition: Healthy
- Keratinized Mucosa Width: Less than 2mm at the intended implant site
- Bucco-lingual Bone Width: At least 5.5 mm in a single edentulous space
- Mesio-distal Distance: At least 7 mm between adjacent teeth in a single edentulous space
Key exclusion criteria (6 listed)
- Cooperation: Uncooperative patients
- Pregnancy: Individuals with known pregnancies
- Parafunctional Habits: Abnormal parafunctional habits such as bruxism and clenching
- Systemic Illnesses: Patients with systemic illnesses that could disrupt healing
- Medication: Individuals receiving systemic corticosteroids or other drugs impacting .osseointegration or post-operative healing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Keratinized Mucosa Width (KMW)
Time frame: Baseline, 1 month, 3 months, 6 months, and 9 months
Measurement Method: The assessment of KMW involved measuring from the alveolar ridge zenith to the muco-gingival junction (MGJ) using a calibrated periodontal probe. Unit of Measure: Millimeters (mm)
Soft Tissue Thickness (STT)
Time frame: Baseline, 1 month, 3 months, 6 months, and 9 months
Measurement Method: STT was determined 1.5 mm apical to the soft tissue margin (STM) using a short anesthesia needle or endodontic micro-opener with a silicon stopper. Unit of Measure: Millimeters (mm) Measurement Procedure: The needle was inserted perpendicular to the mucosal surface, through the soft tissues with light pressure until a hard surface was felt. The silicon stopper was placed in tight contact with the soft tissue surface, and the penetrated part was measured on an endodontic ruler. Measurements were rounded to the nearest half of a millimeter.
Graft Shrinkage
Time frame: 1 month, 3 months, 6 months, and 9 months
The decrease in the size of the graft at each follow-up time was compared to the baseline. size. It was presented in percentage
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 2 Feb 2024.
- 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.
Samah Elmeadawy, Ph.D study director
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gingival Atrophy, run by Mansoura University at 1 site in Egypt.
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 9 inclusion and 6 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 2 Feb 2024. 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 Egypt. 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?
Keratinized Mucosa Width (KMW) (time frame: Baseline, 1 month, 3 months, 6 months, and 9 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 2 Feb 2024.