Effect of I-Shape Incısıon Technique on Inter-Implant Papilla: A Prospective Randomized Clinical Trial

NCT02996370 | Completed

• 1 other identifier: EGE-OP 2013
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

Regenerating a predictable inter-implant papilla is the most complex and challenging aspect of implant dentistry. The aim of the study was to compare the efficacy of I shaped incision technique and conventional midcrestal incision technique for interimplant papilla reconstruction in a 6 month clinical trial.

Conditions

Tooth Loss; Bone Loss

Keywords

esthetic; inter-implant papilla; soft tissue tickness; crestal bone loss; second stage surgery

Outcome Measures

Primary Outcomes (6)

• papilla fill index

  Baseline will be 1 week after cementation of the crowns.

  baseline

• papilla fill index

  Papilla fill index will be recorded 3rd month after baseline

  3 month

• papilla fill index

  Papilla fill index will be recorded 6th month after baseline

  6 month

• crestal bone loss

  Crestal bone loss was measured on radiographs between baseline-3rd month.

  Change from baseline crestal bone level up to 3 months

• crestal bone loss

  Crestal bone loss was measured on radiographs between baseline-6th month.

  Change from baseline crestal bone level up to 6 months

• vertical distance

  Inter-implant vertical distance between the crests top-contact point was also evaluated with digital periapical radiographs.

  baseline, 3 and 6 month

Secondary Outcomes (12)

• Probing depth

  baseline

• Probing depth

  3 month

• Probing depth

  6 month

• Modified sulcus bleeding index

  Modified sulcus bleeding index was recorded at baseline

• Modified sulcus bleeding index

  Modified sulcus bleeding index was recorded at 3 month

Study Arms (2)

Test group- ı shape incision

ACTIVE COMPARATOR

Second stage surgery was made I shape incision technique .

Other: papilla fill index; Other: crestal bone loss; Other: probing depth; Other: Modified sulcus bleeding index; Other: Modified plaque index

Control group- midcrestal incision

ACTIVE COMPARATOR

In the control group second stage surgery was made using the conventional method, midcrestal technique.

Other: papilla fill index; Other: crestal bone loss; Other: probing depth; Other: Modified sulcus bleeding index; Other: Modified plaque index

Interventions

papilla fill index OTHER

The clinical photographs were taken baseline, 3 and 6 month. Two T shaped full-round hexagonal straight filaments, each 5 mm, were used in the taking of standardized images.

Control group- midcrestal incision; Test group- ı shape incision

crestal bone loss OTHER

Crestal bone loss was measured on digital radiographs at baseline, 3 and 6 month with a Java program me (Image-J 3.0 NIH, Bethesda, USA)

Control group- midcrestal incision; Test group- ı shape incision

probing depth OTHER

The change of probing depth between baseline, 3 and 6month. Probing depth was measured with a plastic periodontal probe (mm)

Control group- midcrestal incision; Test group- ı shape incision

Modified sulcus bleeding index OTHER

Modified bleeding index was measured baseline, 3 and 6 month. Presence of bleeding on probing were performed at four sites of implants.

Control group- midcrestal incision; Test group- ı shape incision

Modified plaque index OTHER

Modified plaque index was measured baseline, 3 and 6 month. Presence of plaque index was performed at four sites of implants.

Control group- midcrestal incision; Test group- ı shape incision

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• No sistemic condition, and age \> 18 years,
• healthy soft tissue (bleeding on probing (BOP) ≤ 20%, Plaque Index ≤ 15%,
• in a need of at least two collateral implants in the maxilla from second premolar to second premolar
• sufficient keratinized tissue
• no bone augmentation procedures before implant placement
• use of tobacco 10N ≥ cigarettes daily
• sufficient distance between opposite occluding dentition at the proposed implant sites

You may not qualify if:

• history of aggressive periodontitis,
• systemic diseases such as diabetes
• pregnant or lactating women
• radiation therapy in the head and neck area wihtin the previous 12 months,
• heavy smokers
• bruxism.

Sponsors & Collaborators

• Ege University: lead

MeSH Terms

Conditions

Tooth Loss; Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Özge PEHLİVANOĞLU, PhD,DDS Ege University, School of Dentistry

Study Record Dates

• First Submitted: December 8, 2016
• First Posted: December 19, 2016
• Study Start: October 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: September 1, 2011
• Last Updated: December 19, 2016

Record last verified: 2016-12