Loss of Keratinized Gingiva Around Dental ImplantsNCT03754894
Efficacy of a Ready Made Plastic Stent With Apically Repositioned Flap in Augmentation of the Peri Implant Soft Tissue
A study testing ready made plastic stent application and simple interrupted sutures in people with Loss of Keratinized Gingiva Around Dental Implants, run by Ain Shams University at 1 site in Egypt.
Trial summary
Keratinized gingiva around dental implants are necessary to achieve esthetic appearance in the anterior teeth, also it is more resistant to abrasion, recession, less in plaque accumulation and inflammation, and easy to manipulate during stage two surgery and impression making in prosthetic stage. Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Loss of Keratinized Gingiva Around Dental Implants
- What is being tested?
- ready made plastic stent application and simple interrupted sutures
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2016to Nov 2018
- 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 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1- Healthy adult patients as evidenced by Burkett's oral medicine health history questionnaire.
- 2- Both genders. 3- Age from 20 -50 years old. 4- Having at least one missing tooth at Posterior area (premolars or molars). 5- Attached gingiva width below 3 mm. 6- Patient should agree to sign a written consent after the nature of the study will be explained.
Who cannot join
- Smokers ( >10 cigs/day ) .(Ata-Ali et al , 2015)
- Vulnerable groups (as pregnant females and decisional impaired individuals) will be excluded from the study.
- Patients with poor oral hygiene or not willing to perform oral hygiene measures.
- Prisoners and handicapped patients.
- Patients with periodontal or periapical infections.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Using a Ready Made Plastic Stent With Apically Repositioned Flap in Augmentation of the Peri Implant Soft Tissue Randomized Clinical Study
Keratinized gingiva around dental implants are necessary to achieve esthetic appearance in the anterior teeth, also it is more resistant to abrasion, recession, less in plaque accumulation and inflammation, and easy to manipulate during stage two surgery and impression making in prosthetic stage. For the aforementioned reasons over year's authors have developed many techniques to increase the amount of keratinized gingiva around the dental implants such techniques are apically and laterally repositioned flaps , free gingival grafts, acellular dermal matrix allograft , coronally repositioned flap and sub epithelial connective tissue flaps . Huh et al compared the effects of the use of a ready-made plastic stent on the width of peri-implant keratinized mucosa with those of conventional methods. In addition, the effect of a plastic stent on peri-implant soft tissue was examined through histological observations. Reported that the width of the keratinized mucosa was significantly higher and the distance from the top of the implant platform to the mucogingival junction was significantly longer in the ready-made plastic stent group.
Thus this study will be performed to compare between the effect of the use of a ready- made plastic stent on the width of peri-implant keratinized tissue and that of conventional methods during first stage of implant surgery.
Read the detailed description
This prospective clinical study will be conducted on Twenty patients will be selected from the outpatient clinic of Oral Medicine, Periodontology, and Oral Diagnosis department, Faculty of Dentistry, Ain Shams University This methodology will be reviewed by Ain shams university, faculty of dentistry research ethics committee
Inclusion criteria:
- Healthy adult patients as evidenced by Burkett's oral medicine health history questionnaire.
- Both genders.
- Age from 20 -50 years old.
- Having at least one missing tooth at Posterior area (premolars or molars).
- Attached gingiva width below 3 mm.
- Patient should agree to sign a written consent after the nature of the study will be explained.
Exclusion criteria:
- Smokers ( >10 cigs/day ) .
- Vulnerable groups (as pregnant females and decisional impaired individuals) will be excluded from the study.
- Patients with poor oral hygiene or not willing to perform oral hygiene measures.
- Prisoners and handicapped patients.
- Patients with periodontal or periapical infections.
Patients met the eligibility criteria will be randomly allocated using computer assisted randomization through numbered sealed envelopes into two treatment modalities groups: -
Group I (with ready-made plastic stent): Will include 10 patients where combined full / partial thickness apically repositioned flap with paracrestal lingual incision will be performed for implant placement followed by healing abutment placement covered by ready-made plastic stent.
Group II (control): Will include 10 patients where combined full / partial thickness apically repositioned flap with paracrestal lingual incision will be performed for implant placement followed by healing abutment placement then suturing the flap in place.
All patients will receive healing abutments in first stage of implant surgery.
This proposal will be reviewed by the research ethics committee, the procedure will be fully explained to the patients and they will sign an informed consent
- Being tested
- ready made plastic stent application, simple interrupted sutures
- Keywords
- dental implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ready made plastic stent applicationDevice
full / partial thickness apically repositioned flap with paracrestal lingual incision will be performed for implant placement followed by healing abutment placement covered by ready-made plastic stent.
simple interrupted suturesProcedure or surgery
full / partial thickness apically repositioned flap with paracrestal lingual incision will be performed for implant placement followed by healing abutment placement and securing the flap with simple interrupted sutures
| Study group | Role | What they receive |
|---|---|---|
| goup 1(with readymade plastic stent ) | Experimental | Will include 10 patients where combined full / partial thickness apically repositioned flap with paracrestal lingual incision will be performed for implant placement followed by healing abutment placement covered by ready-made plastic stent. Receives: Device: ready made plastic stent application |
| group 2 (control) | Experimental | Will include 10 patients where combined full / partial thickness apically repositioned flap with paracrestal lingual incision will be performed for implant placement followed by healing abutment placement then suturing the flap in place. Receives: Procedure: simple interrupted sutures |
What is being measured
The primary outcome is the main question the study is designed to answer.
increasing attached gingiva width around implant
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study startDec 2016
- Primary completionMar 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Loss of Keratinized Gingiva Around Dental ImplantsStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ahmed hamdy mahmoud, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03754894
- Sponsor's protocol ID
- per- 16 29 M
- Status last verified
- May 2021
- First submitted
- 23 Nov 2018
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Hamdy A, Abd El Gaber HK, Ghalwash DM, Abbas WM. Effect of Using a Plastic Stent with Apically Repositioned Flap in Peri-Implant Soft Tissue Augmentation: A Randomized Controlled Clinical Trial. Int J Dent. 2021 May 18;2021:5590400. doi: 10.1155/2021/5590400. eCollection 2021.
PubMed 34113381
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Using a Ready Made Plastic Stent With Apically Repositioned Flap in Augmentation of the Peri Implant Soft Tissue Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT03754894
- Acronym / sponsor ID
- per- 16 29 M
- Keywords
- dental implants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 27 Nov 2018 (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.
Keratinized gingiva around dental implants are necessary to achieve esthetic appearance in the anterior teeth, also it is more resistant to abrasion, recession, less in plaque accumulation and inflammation, and easy to manipulate during stage two surgery and impression making in prosthetic stage. For the aforementioned reasons over year's authors have developed many techniques to increase the amount of keratinized gingiva around the dental implants such techniques are apically and laterally repositioned flaps , free gingival grafts, acellular dermal matrix allograft , coronally repositioned flap and sub epithelial connective tissue flaps . Huh et al compared the effects of the use of a ready-made plastic stent on the width of peri-implant keratinized mucosa with those of conventional methods. In addition, the effect of a plastic stent on peri-implant soft tissue was examined through histological observations. Reported that the width of the keratinized mucosa was significantly higher and the distance from the top of the implant platform to the mucogingival junction was significantly longer in the ready-made plastic stent group.
Thus this study will be performed to compare between the effect of the use of a ready- made plastic stent on the width of peri-implant keratinized tissue and that of conventional methods during first stage of implant surgery.
Detailed description
This prospective clinical study will be conducted on Twenty patients will be selected from the outpatient clinic of Oral Medicine, Periodontology, and Oral Diagnosis department, Faculty of Dentistry, Ain Shams University This methodology will be reviewed by Ain shams university, faculty of dentistry research ethics committee
Inclusion criteria:
- Healthy adult patients as evidenced by Burkett's oral medicine health history questionnaire.
- Both genders.
- Age from 20 -50 years old.
- Having at least one missing tooth at Posterior area (premolars or molars).
- Attached gingiva width below 3 mm.
- Patient should agree to sign a written consent after the nature of the study will be explained.
Exclusion criteria:
- Smokers ( >10 cigs/day ) .
- Vulnerable groups (as pregnant females and decisional impaired individuals) will be excluded from the study.
- Patients with poor oral hygiene or not willing to perform oral hygiene measures.
- Prisoners and handicapped patients.
- Patients with periodontal or periapical infections.
Patients met the eligibility criteria will be randomly allocated using computer assisted randomization through numbered sealed envelopes into two treatment modalities groups: -
Group I (with ready-made plastic stent): Will include 10 patients where combined full / partial thickness apically repositioned flap with paracrestal lingual incision will be performed for implant placement followed by healing abutment placement covered by ready-made plastic stent.
Group II (control): Will include 10 patients where combined full / partial thickness apically repositioned flap with paracrestal lingual incision will be performed for implant placement followed by healing abutment placement then suturing the flap in place.
All patients will receive healing abutments in first stage of implant surgery.
This proposal will be reviewed by the research ethics committee, the procedure will be fully explained to the patients and they will sign an informed consent
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| goup 1(with readymade plastic stent ) | Experimental | Device: ready made plastic stent applicationWill include 10 patients where combined full / partial thickness apically repositioned flap with paracrestal lingual incision will be performed for implant placement followed by healing abutment placement covered by ready-made plastic stent. |
| group 2 (control) | Experimental | Procedure: simple interrupted suturesWill include 10 patients where combined full / partial thickness apically repositioned flap with paracrestal lingual incision will be performed for implant placement followed by healing abutment placement then suturing the flap in place. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 1- Healthy adult patients as evidenced by Burkett's oral medicine health history questionnaire.
- 2- Both genders. 3- Age from 20 -50 years old. 4- Having at least one missing tooth at Posterior area (premolars or molars). 5- Attached gingiva width below 3 mm. 6- Patient should agree to sign a written consent after the nature of the study will be explained.
Key exclusion criteria (6 listed)
- Smokers ( >10 cigs/day ) .(Ata-Ali et al , 2015)
- Vulnerable groups (as pregnant females and decisional impaired individuals) will be excluded from the study.
- Patients with poor oral hygiene or not willing to perform oral hygiene measures.
- Prisoners and handicapped patients.
- Patients with periodontal or periapical infections.
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 |
|---|---|---|
| ready made plastic stent applicationfull / partial thickness apically repositioned flap with paracrestal lingual incision will be performed for implant placement followed by healing abutment placement covered by ready-made plastic stent. | Device | goup 1(with readymade plastic stent ) |
| simple interrupted suturesfull / partial thickness apically repositioned flap with paracrestal lingual incision will be performed for implant placement followed by healing abutment placement and securing the flap with simple interrupted sutures | Procedure or surgery | group 2 (control) |
Primary outcome
increasing attached gingiva width around implant
Time frame: 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 6 May 2021.
- Derived from this study: PubMed 34113381Hamdy A, Abd El Gaber HK, Ghalwash DM, Abbas WM. Effect of Using a Plastic Stent with Apically Repositioned Flap in Peri-Implant Soft Tissue Augmentation: A Randomized Controlled Clinical Trial. Int J Dent. 2021 May 18;2021:5590400. doi: 10.1155/2021/5590400. eCollection 2021.
- Individual participant dataSharing planned: Undecided
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 ready made plastic stent application and simple interrupted sutures in people with Loss of Keratinized Gingiva Around Dental Implants, run by Ain Shams 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 2 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 6 May 2021. 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?
increasing attached gingiva width around implant (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03754894, which also lists 1 linked publication.
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 6 May 2021.