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

Effect of Using a Ready Made Plastic Stent With Apically Repositioned Flap in Augmentation of the Peri Implant Soft Tissue Randomized Clinical Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03754894
Enrollment
20
Registered
2018-11-27
Start date
2016-12-31
Completion date
2018-11-30
Last updated
2021-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Loss of Keratinized Gingiva Around Dental Implants

Keywords

dental implants

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.

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

Interventions

DEVICEready 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.

PROCEDUREsimple 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

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
30 Years to 50 Years
Healthy volunteers
Yes

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. \-

Design outcomes

Primary

MeasureTime frame
increasing attached gingiva width around implant6 months

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026