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

NCT ID: NCT03754894

Last Updated: 2021-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2018-11-30

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

Conditions

Loss of Keratinized Gingiva Around Dental Implants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

ready made plastic stent application

Intervention Type: DEVICE

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)

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.

Group Type: EXPERIMENTAL

simple interrupted sutures

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: DEVICE

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

Intervention Type: PROCEDURE

Eligibility 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.

-

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

ahmed hamdy mahmoud

teaching assistant of oral medicine and periodontology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ainshams Dental School

Cairo, , Egypt

Countries

Egypt

References

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.

Reference Type: DERIVED

PMID: 34113381 (View on PubMed)

Other Identifiers

per- 16 29 M

Identifier Type: -

Identifier Source: org_study_id