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Efficacy of a Ready Made Plastic Stent With Apically Repositioned Flap in Augmentation of the Peri Implant Soft Tissue

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ClinicalTrials.gov Identifier: NCT03754894
Recruitment Status : Completed
First Posted : November 27, 2018
Last Update Posted : May 6, 2021
Sponsor:
Information provided by (Responsible Party):
ahmed hamdy mahmoud, Ain Shams University

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Loss of Keratinized Gingiva Around Dental Implants Device: ready made plastic stent application Procedure: simple interrupted sutures Not Applicable

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:

  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.

Exclusion criteria:

  1. Smokers ( >10 cigs/day ) .
  2. Vulnerable groups (as pregnant females and decisional impaired individuals) will be excluded from the study.
  3. Patients with poor oral hygiene or not willing to perform oral hygiene measures.
  4. Prisoners and handicapped patients.
  5. 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : December 2016
Actual Primary Completion Date : March 2018
Actual Study Completion Date : November 2018

Arm Intervention/treatment
Experimental: goup 1(with readymade 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.
Device: ready made plastic stent application
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.

Experimental: group 2 (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.
Procedure: simple interrupted sutures
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




Primary Outcome Measures :
  1. increasing attached gingiva width around implant [ Time Frame: 6 months ]


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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

  1. Smokers ( >10 cigs/day ) .(Ata-Ali et al , 2015)
  2. Vulnerable groups (as pregnant females and decisional impaired individuals) will be excluded from the study.
  3. Patients with poor oral hygiene or not willing to perform oral hygiene measures.
  4. Prisoners and handicapped patients.
  5. Patients with periodontal or periapical infections.

    -


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03754894


Locations
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Egypt
Ainshams Dental School
Cairo, Egypt, 11516
Sponsors and Collaborators
Ain Shams University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: ahmed hamdy mahmoud, teaching assistant of oral medicine and periodontology, Ain Shams University
ClinicalTrials.gov Identifier: NCT03754894    
Other Study ID Numbers: per- 16 29 M
First Posted: November 27, 2018    Key Record Dates
Last Update Posted: May 6, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by ahmed hamdy mahmoud, Ain Shams University:
dental implants